Perrigouk
Select how often (in days) to receive an alert: Assistant Professional Regulatory Affairs- Lifecycle Management -Medical Devices Location: London, GB, SW11 7BW At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill , Compeed , Solpadeine , NiQuitin , and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview We are excited to recruit a Regulatory Affairs Assitant Professional within our Medical Device Lifecycle Management team. You will support Perrigo's medical device portfolio throughout the product lifecycle, contributing to regulatory activities that help maintain product compliance, availability and market access across multiple markets. Working with cross-functional stakeholders including Quality, Safety, Supply Chain, Manufacturing, R&D and Regulatory Operations, you will provide regulatory support for product, labelling, process and documentation changes and assist in implementing regulatory requirements that support compliance and business needs. You will contribute to the continuous improvement of Regulatory Affairs processes, systems and ways of working, helping to improve efficiency, consistency and quality across medical device lifecycle activities. Through your role, you will develop foundational knowledge of medical device regulations and gain experience working within a global regulatory environment. This role offers an excellent opportunity to begin or further develop a career in Medical Device Regulatory Affairs, building technical expertise, regulatory knowledge and professional capabilities while supporting Perrigo's commitment to maintaining high standards of compliance, consumer safety and product quality. Scope of the Role Supports the compliant maintenance of Perrigo's medical device portfolio by contributing to lifecycle regulatory activities, documentation quality, and implementation tracking across products and markets. Provides a pathway into Regulatory Affairs for either a graduate building foundational regulatory capability or an experienced administrator/coordinator moving into a regulatory career pathway. Builds practical understanding of medical device regulatory delivery while operating with agility across changing priorities and supporting a flexible work remit in line with business needs. Supports post-launch regulatory execution for medical devices under the direction of more experienced regulatory colleagues. Works across change documentation, trackers, technical documentation updates and basic implementation support for defined products or workstreams. Contributes within project teams with no people leadership and increasing exposure to product types, markets, and regulatory systems. Lifecycle Delivery Support Support preparation, compilation, and maintenance of medical device regulatory documentation, technical documentation, records, and trackers. Assist with planning and tracking for post-market changes, notifications, registrations, renewals, and related maintenance activities. Gather and organise source information required to support regulatory assessments, technical documentation updates, and implementation activities. Contribute to accurate implementation tracking for approved changes to help protect compliance, product availability and continuity of supply. Compliance, Documentation & Process Discipline Maintain records and documentation in line with Good Documentation Practice and established regulatory and quality processes. Support responses to routine internal or external regulatory queries, including notified body or competent authority information requests, under guidance. Escalate uncertainties, gaps, or risks promptly and accurately. Contribute to disciplined handover and transition of regulatory information, decisions, and files across interfaces. Build understanding of medical device lifecycle processes, regulatory requirements, systems, and terminology across products and markets. Work effectively with Medical Device Regulatory Affairs, Lifecycle Management, Category, Cluster, Quality, Safety, R&D, Supply, Artwork, and Regulatory Operations colleagues. Demonstrate flexibility to support a range of administrative, coordination, and entry-level regulatory activities depending on business priorities. Experience Required Degree in Life Sciences or a related discipline, or relevant administrative/co-ordination experience in a regulated, quality-driven, or document-intensive environment. This role is suitable for candidates with up to 2 years' Regulatory Affairs experience, preferably within medical devices or another regulated healthcare product area. Strong organisational skills, attention to detail, and the ability to manage information accurately in a structured environment. Demonstrated ability to work collaboratively and learn quickly. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Hybrid Working Approach We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out morehere We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.
Select how often (in days) to receive an alert: Assistant Professional Regulatory Affairs- Lifecycle Management -Medical Devices Location: London, GB, SW11 7BW At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill , Compeed , Solpadeine , NiQuitin , and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview We are excited to recruit a Regulatory Affairs Assitant Professional within our Medical Device Lifecycle Management team. You will support Perrigo's medical device portfolio throughout the product lifecycle, contributing to regulatory activities that help maintain product compliance, availability and market access across multiple markets. Working with cross-functional stakeholders including Quality, Safety, Supply Chain, Manufacturing, R&D and Regulatory Operations, you will provide regulatory support for product, labelling, process and documentation changes and assist in implementing regulatory requirements that support compliance and business needs. You will contribute to the continuous improvement of Regulatory Affairs processes, systems and ways of working, helping to improve efficiency, consistency and quality across medical device lifecycle activities. Through your role, you will develop foundational knowledge of medical device regulations and gain experience working within a global regulatory environment. This role offers an excellent opportunity to begin or further develop a career in Medical Device Regulatory Affairs, building technical expertise, regulatory knowledge and professional capabilities while supporting Perrigo's commitment to maintaining high standards of compliance, consumer safety and product quality. Scope of the Role Supports the compliant maintenance of Perrigo's medical device portfolio by contributing to lifecycle regulatory activities, documentation quality, and implementation tracking across products and markets. Provides a pathway into Regulatory Affairs for either a graduate building foundational regulatory capability or an experienced administrator/coordinator moving into a regulatory career pathway. Builds practical understanding of medical device regulatory delivery while operating with agility across changing priorities and supporting a flexible work remit in line with business needs. Supports post-launch regulatory execution for medical devices under the direction of more experienced regulatory colleagues. Works across change documentation, trackers, technical documentation updates and basic implementation support for defined products or workstreams. Contributes within project teams with no people leadership and increasing exposure to product types, markets, and regulatory systems. Lifecycle Delivery Support Support preparation, compilation, and maintenance of medical device regulatory documentation, technical documentation, records, and trackers. Assist with planning and tracking for post-market changes, notifications, registrations, renewals, and related maintenance activities. Gather and organise source information required to support regulatory assessments, technical documentation updates, and implementation activities. Contribute to accurate implementation tracking for approved changes to help protect compliance, product availability and continuity of supply. Compliance, Documentation & Process Discipline Maintain records and documentation in line with Good Documentation Practice and established regulatory and quality processes. Support responses to routine internal or external regulatory queries, including notified body or competent authority information requests, under guidance. Escalate uncertainties, gaps, or risks promptly and accurately. Contribute to disciplined handover and transition of regulatory information, decisions, and files across interfaces. Build understanding of medical device lifecycle processes, regulatory requirements, systems, and terminology across products and markets. Work effectively with Medical Device Regulatory Affairs, Lifecycle Management, Category, Cluster, Quality, Safety, R&D, Supply, Artwork, and Regulatory Operations colleagues. Demonstrate flexibility to support a range of administrative, coordination, and entry-level regulatory activities depending on business priorities. Experience Required Degree in Life Sciences or a related discipline, or relevant administrative/co-ordination experience in a regulated, quality-driven, or document-intensive environment. This role is suitable for candidates with up to 2 years' Regulatory Affairs experience, preferably within medical devices or another regulated healthcare product area. Strong organisational skills, attention to detail, and the ability to manage information accurately in a structured environment. Demonstrated ability to work collaboratively and learn quickly. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Hybrid Working Approach We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out morehere We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.
Perrigouk
Braunton, Devon
Select how often (in days) to receive an alert: At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill , Compeed , Solpadeine , NiQuitin , and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview Support the Operational Excellence Manager in driving the CI strategy. To utilise cross functional teams to drive projects focused on Capability & Capacity improvements across the site. Help build systems which drive the Lean Sigma transformation process and through training & coaching, embed the desired core values, principles & behaviours. Evaluate product Quality through Quantitative & Qualitative data analysis to ensure products & processes are consistently produced within their quality critical attributes. Support the investigation of complex Deviations and to propose and implement corrective actions and permanent solutions to prevent recurrence. Scope of the Role Liaise with PWS ( Perrigo Work System) Site Lead / OPEX Manager and wider Operational teams. Facilitate PWS material development i.e. Play book for DMS, SOP, Quick Fix routine, and keeping them current. Facilitate and support shift teams shift handover meetings, Shift huddles and support Leader Standard Work. Facilitate and ensure the introduction of new practices and behaviour in the line/process areas. Play an active role in maturity assessment. Facilitate implementation of best practices and provide inputs for Pillar maturity assessments and associated actions plan. Facilitate detailed PWS Phase Implementation Plan and bring to life the KPI's. Facilitate and support identification and elimination of waste using lean tools i.e. 5S, Problem Solving, Kaizens etc. Identify and promote best practice across all areas within the site. Support the Deployment of the foundational Lean Tools at Braunton. Working with the operations team and others where required, to embed continuous improvement & desired principles, systems & behaviours across all processes. Organise, lead and support improvements including Kaizen Events providing clear benefits and improvement goals for each event which align with the site KPI and or stimulate the reduction of waste. Supporting investigations into complex Deviations and assisting in rectification and resolution. Experience Required University Degree, Minimum of 2 years' experience of tablet/capsule manufacture, within the pharmaceutical or other regulated industry. Strong knowledge of cGMP and MHRA regulatory requirements. A practical knowledge of Six Sigma and the principles of Lean management, along with experience of working in an environment employing some elements of continuous improvement would also be beneficial. Strong analytical, problem-solving, and data interpretation skills. Effective communication and stakeholder engagement across all levels. Ability to translate and communicate deployment plans to shift teams to gain buy in. Ability to manage multiple priorities in a fast-paced environment. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out morehere We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.
Select how often (in days) to receive an alert: At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill , Compeed , Solpadeine , NiQuitin , and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview Support the Operational Excellence Manager in driving the CI strategy. To utilise cross functional teams to drive projects focused on Capability & Capacity improvements across the site. Help build systems which drive the Lean Sigma transformation process and through training & coaching, embed the desired core values, principles & behaviours. Evaluate product Quality through Quantitative & Qualitative data analysis to ensure products & processes are consistently produced within their quality critical attributes. Support the investigation of complex Deviations and to propose and implement corrective actions and permanent solutions to prevent recurrence. Scope of the Role Liaise with PWS ( Perrigo Work System) Site Lead / OPEX Manager and wider Operational teams. Facilitate PWS material development i.e. Play book for DMS, SOP, Quick Fix routine, and keeping them current. Facilitate and support shift teams shift handover meetings, Shift huddles and support Leader Standard Work. Facilitate and ensure the introduction of new practices and behaviour in the line/process areas. Play an active role in maturity assessment. Facilitate implementation of best practices and provide inputs for Pillar maturity assessments and associated actions plan. Facilitate detailed PWS Phase Implementation Plan and bring to life the KPI's. Facilitate and support identification and elimination of waste using lean tools i.e. 5S, Problem Solving, Kaizens etc. Identify and promote best practice across all areas within the site. Support the Deployment of the foundational Lean Tools at Braunton. Working with the operations team and others where required, to embed continuous improvement & desired principles, systems & behaviours across all processes. Organise, lead and support improvements including Kaizen Events providing clear benefits and improvement goals for each event which align with the site KPI and or stimulate the reduction of waste. Supporting investigations into complex Deviations and assisting in rectification and resolution. Experience Required University Degree, Minimum of 2 years' experience of tablet/capsule manufacture, within the pharmaceutical or other regulated industry. Strong knowledge of cGMP and MHRA regulatory requirements. A practical knowledge of Six Sigma and the principles of Lean management, along with experience of working in an environment employing some elements of continuous improvement would also be beneficial. Strong analytical, problem-solving, and data interpretation skills. Effective communication and stakeholder engagement across all levels. Ability to translate and communicate deployment plans to shift teams to gain buy in. Ability to manage multiple priorities in a fast-paced environment. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out morehere We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.
Perrigouk
Select how often (in days) to receive an alert: Manager - Regulatory Affairs Lifecycle Management - Medicines Location: London, GB, SW11 7BW At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview We re excited to recruit a Manager as Medicines Lead for Lifecycle Management. You will play a key role in delivering Perrigo's regulatory strategy across the medicines product lifecycle. You will lead the development and execution of post-approval regulatory strategies, ensuring the consistent delivery of high-quality regulatory outcomes across a diverse and complex medicines portfolio. You will be responsible for managing lifecycle management activities, overseeing the preparation, submission, and maintenance of regulatory dossiers and Marketing Authorisations in line with global requirements and business priorities. You will proactively identify risks, support mitigation planning, and ensure timely, compliant submissions that help maintain supply continuity, consumer and patient safety, and market access. Leading a team of multi-regional regulatory professionals, you will provide clear direction, support capability development, and foster a culture of accountability and continuous improvement. You will manage priorities across multiple activities, ensuring effective execution and alignment with departmental and organisational goals. Working closely with cross-functional stakeholders-including Quality, Safety, Supply Chain, and R&D-you will contribute regulatory expertise to change management and business initiatives. You will help translate regulatory requirements into practical, actionable plans that support product maintenance, compliance, and portfolio optimisation. You will also contribute to the continuous improvement of Regulatory Affairs processes and ways of working, helping to drive efficiency, consistency, and scalability across lifecycle activities. Through your role, you will support Perrigo's ability to meet evolving regulatory requirements while maintaining high standards of compliance and quality. This role offers the opportunity to make a meaningful impact within the Regulatory Affairs organisation-supporting product availability and regulatory performance while developing your leadership and technical expertise in a dynamic, global environment. Scope of the Role Leads Lifecycle Management Regulatory Affairs for the assigned portfolio and is accountable for post-launch regulatory strategy, compliance performance, and delivery outcomes. Sets direction, priorities, and governance to ensure compliant and timely execution of post-approval activities while balancing business needs, consumer or patient protection, and supply continuity. Leads, develops, and performance-manages a team and shapes capability while driving a consistent One Regulatory Voice across the organisation. Owns governance and decision-making for post-approval changes across the medicines portfolio, including variations, renewals, PV-related regulatory commitments and reporting, maintenance and supply-driven changes, and regulatory intelligence-driven changes. Establishes robust change control management with Quality, Supply Chain, and R&D and oversees impact assessments, submission strategy, implementation tracking, dossier integrity, inspection readiness, and metrics. Acts as final decision-maker within delegated authorities for lifecycle change strategy, prioritisation, resourcing, and governance, escalating enterprise policy or high-risk precedent decisions as required. Lifecycle Strategy, Governance & Delivery Own post-launch regulatory strategy and compliance for the medicines portfolio, including variations, renewals, PV-related regulatory commitments and reporting, maintenance and supply-driven changes, and regulatory intelligence-driven changes. Establish robust change control with Quality, Supply Chain, and R&D, ensuring impact assessments, submission strategy, implementation tracking, and inspection readiness are effective and sustainable. Partner with Pharmacovigilance and Medical/Safety teams on safety-driven variations, product information updates, risk minimisation measures, PV-related regulatory commitments, and reporting requirements. Ensure timely, compliant execution of lifecycle submissions and commitments; monitor performance and remove barriers to delivery. Monitor and interpret regulatory trends and legislation; provide timely impact assessments and lead mitigation planning and CAPA governance to protect compliance and avoid supply disruption. Lead authority interactions and escalations for lifecycle topics and represent Perrigo in local or cluster forums and trade associations where required. Provide portfolio planning input for major changes, site transfers, cost optimisation, and portfolio optimisation or discontinuation decisions, ensuring regulatory feasibility and timelines are understood. Leadership, Capability & Operational Excellence Lead and develop the team; set objectives, coach performance, build succession, and shape capability. Drive harmonisation of SOPs and templates, oversee RIMS and workflow data quality, and use metrics to improve cycle times and accountability in partnership with RegOps. Lead governance forums, escalation pathways, and cross-functional alignment so dossiers, decisions, and implementation requirements transition cleanly across Category, Cluster, and LCM interfaces. Experience Required Typically 8-10+ years in Regulatory Affairs with strong medicines lifecycle or post-launch compliance expertise, including knowledge of global medicines regulatory frameworks, post-approval variation requirements, CTD/eCTD dossier requirements, and lifecycle maintenance of Marketing Authorisations; relevant scientific or technical degree preferred. Demonstrated people leadership, authority engagement, and experience managing competing priorities across a portfolio. Experience working cross-functionally in a matrixed organization and providing strong regulatory writing and stakeholder management. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Hybrid Working Approach We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.
Select how often (in days) to receive an alert: Manager - Regulatory Affairs Lifecycle Management - Medicines Location: London, GB, SW11 7BW At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview We re excited to recruit a Manager as Medicines Lead for Lifecycle Management. You will play a key role in delivering Perrigo's regulatory strategy across the medicines product lifecycle. You will lead the development and execution of post-approval regulatory strategies, ensuring the consistent delivery of high-quality regulatory outcomes across a diverse and complex medicines portfolio. You will be responsible for managing lifecycle management activities, overseeing the preparation, submission, and maintenance of regulatory dossiers and Marketing Authorisations in line with global requirements and business priorities. You will proactively identify risks, support mitigation planning, and ensure timely, compliant submissions that help maintain supply continuity, consumer and patient safety, and market access. Leading a team of multi-regional regulatory professionals, you will provide clear direction, support capability development, and foster a culture of accountability and continuous improvement. You will manage priorities across multiple activities, ensuring effective execution and alignment with departmental and organisational goals. Working closely with cross-functional stakeholders-including Quality, Safety, Supply Chain, and R&D-you will contribute regulatory expertise to change management and business initiatives. You will help translate regulatory requirements into practical, actionable plans that support product maintenance, compliance, and portfolio optimisation. You will also contribute to the continuous improvement of Regulatory Affairs processes and ways of working, helping to drive efficiency, consistency, and scalability across lifecycle activities. Through your role, you will support Perrigo's ability to meet evolving regulatory requirements while maintaining high standards of compliance and quality. This role offers the opportunity to make a meaningful impact within the Regulatory Affairs organisation-supporting product availability and regulatory performance while developing your leadership and technical expertise in a dynamic, global environment. Scope of the Role Leads Lifecycle Management Regulatory Affairs for the assigned portfolio and is accountable for post-launch regulatory strategy, compliance performance, and delivery outcomes. Sets direction, priorities, and governance to ensure compliant and timely execution of post-approval activities while balancing business needs, consumer or patient protection, and supply continuity. Leads, develops, and performance-manages a team and shapes capability while driving a consistent One Regulatory Voice across the organisation. Owns governance and decision-making for post-approval changes across the medicines portfolio, including variations, renewals, PV-related regulatory commitments and reporting, maintenance and supply-driven changes, and regulatory intelligence-driven changes. Establishes robust change control management with Quality, Supply Chain, and R&D and oversees impact assessments, submission strategy, implementation tracking, dossier integrity, inspection readiness, and metrics. Acts as final decision-maker within delegated authorities for lifecycle change strategy, prioritisation, resourcing, and governance, escalating enterprise policy or high-risk precedent decisions as required. Lifecycle Strategy, Governance & Delivery Own post-launch regulatory strategy and compliance for the medicines portfolio, including variations, renewals, PV-related regulatory commitments and reporting, maintenance and supply-driven changes, and regulatory intelligence-driven changes. Establish robust change control with Quality, Supply Chain, and R&D, ensuring impact assessments, submission strategy, implementation tracking, and inspection readiness are effective and sustainable. Partner with Pharmacovigilance and Medical/Safety teams on safety-driven variations, product information updates, risk minimisation measures, PV-related regulatory commitments, and reporting requirements. Ensure timely, compliant execution of lifecycle submissions and commitments; monitor performance and remove barriers to delivery. Monitor and interpret regulatory trends and legislation; provide timely impact assessments and lead mitigation planning and CAPA governance to protect compliance and avoid supply disruption. Lead authority interactions and escalations for lifecycle topics and represent Perrigo in local or cluster forums and trade associations where required. Provide portfolio planning input for major changes, site transfers, cost optimisation, and portfolio optimisation or discontinuation decisions, ensuring regulatory feasibility and timelines are understood. Leadership, Capability & Operational Excellence Lead and develop the team; set objectives, coach performance, build succession, and shape capability. Drive harmonisation of SOPs and templates, oversee RIMS and workflow data quality, and use metrics to improve cycle times and accountability in partnership with RegOps. Lead governance forums, escalation pathways, and cross-functional alignment so dossiers, decisions, and implementation requirements transition cleanly across Category, Cluster, and LCM interfaces. Experience Required Typically 8-10+ years in Regulatory Affairs with strong medicines lifecycle or post-launch compliance expertise, including knowledge of global medicines regulatory frameworks, post-approval variation requirements, CTD/eCTD dossier requirements, and lifecycle maintenance of Marketing Authorisations; relevant scientific or technical degree preferred. Demonstrated people leadership, authority engagement, and experience managing competing priorities across a portfolio. Experience working cross-functionally in a matrixed organization and providing strong regulatory writing and stakeholder management. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Hybrid Working Approach We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.