Job Description
RBW are collaborating with a leading international biotech to find an Associate Director of Regulatory Affairs Strategy, who will participate in the development and implementation of regulatory strategy for a range of therapeutic areas, including Pulmonology/Respiratory, Haematology, Diabetes and Gene therapies. The role is based in their international HQ in London.
Role Responsibilities:
Act as the Regional Regulatory Lead, to develop regulatory strategy for assigned products in collaboration with Global Regulatory Lead
Ensure projects are appropriately prioritised and progressed in accordance with agreed regulatory plans, communicating any identified risks to project teams and Senior Management
Manage the preparation and submission of technically complex regulatory submissions, with minimal supervision
Provide appropriate strategic regulatory advice to Submission and Project Teams in a timely manner
Keep regulatory affairs senior management informed on the status of global strategies and tactics, procedures and practices, with a focus on regulatory and policy trends in the EU
Act as primary contact with Regulatory Authorities for assigned products and territories
Lead local or global company process improvement initiatives
Ensure all work is compliant with regulatory requirements and company policies and procedures
Work with cross-department teams and key IHQ functions to achieve corporate and departmental goals and objectives.
Able to plan, schedule and arrange own work activities with limited direction, exhibiting ownership and accountability for all projects and internal assignments
Role Requirements:
Bachelor s degree in life sciences
Recent direct experience of clinical development
Has led direct interactions with EMA, and national Competent Authorities on clinical development and complex regulatory submissions such as MAAs, new indications, and PIPs
In-depth knowledge of regulatory landscape, including ICH and regional requirements for assigned territories and current regulatory trends
Recognized as a knowledgeable resource for regulatory advice in other departments
Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society
Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct
Strategic ability, as evidenced by an awareness of the "big picture" strategic issues facing the business overall and positioning of local strategy relative to global and international requirements
Ability to navigate and be successful in a fast-paced environment while delivering high quality results
Adaptable to changing plans and able to behave independently with minimal guidance where needed, but also embraces being part of a team and working collaboratively
Good interpersonal skills and ability to deal effectively with a variety of personalities
Acts to promote an energizing, inclusive environment and good morale
Empowers other team members through delegation of tasks and decisions
Excellent communication skills, strong oral/written presentation skills.
Fluent written and spoken English.
Ability to travel to corporate headquarters as well as attend EU meetings as required
This role provides hybrid working from home and a Central London office, and a strong culture with the support and opportunities to progress further into your career. Alongside this, my client also offers a comprehensive benefits package, including a generous bonus scheme, LTI s, healthcare, and a car allowance.
My client are able to offer visa sponsorship and relocation support to candidates with relevant capabilities.
If you have the skills required and would like to discuss the full details of the job, please contact Katie Dunbar on 952176, or apply with your CV.
Role Responsibilities:
Act as the Regional Regulatory Lead, to develop regulatory strategy for assigned products in collaboration with Global Regulatory Lead
Ensure projects are appropriately prioritised and progressed in accordance with agreed regulatory plans, communicating any identified risks to project teams and Senior Management
Manage the preparation and submission of technically complex regulatory submissions, with minimal supervision
Provide appropriate strategic regulatory advice to Submission and Project Teams in a timely manner
Keep regulatory affairs senior management informed on the status of global strategies and tactics, procedures and practices, with a focus on regulatory and policy trends in the EU
Act as primary contact with Regulatory Authorities for assigned products and territories
Lead local or global company process improvement initiatives
Ensure all work is compliant with regulatory requirements and company policies and procedures
Work with cross-department teams and key IHQ functions to achieve corporate and departmental goals and objectives.
Able to plan, schedule and arrange own work activities with limited direction, exhibiting ownership and accountability for all projects and internal assignments
Role Requirements:
Bachelor s degree in life sciences
Recent direct experience of clinical development
Has led direct interactions with EMA, and national Competent Authorities on clinical development and complex regulatory submissions such as MAAs, new indications, and PIPs
In-depth knowledge of regulatory landscape, including ICH and regional requirements for assigned territories and current regulatory trends
Recognized as a knowledgeable resource for regulatory advice in other departments
Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society
Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct
Strategic ability, as evidenced by an awareness of the "big picture" strategic issues facing the business overall and positioning of local strategy relative to global and international requirements
Ability to navigate and be successful in a fast-paced environment while delivering high quality results
Adaptable to changing plans and able to behave independently with minimal guidance where needed, but also embraces being part of a team and working collaboratively
Good interpersonal skills and ability to deal effectively with a variety of personalities
Acts to promote an energizing, inclusive environment and good morale
Empowers other team members through delegation of tasks and decisions
Excellent communication skills, strong oral/written presentation skills.
Fluent written and spoken English.
Ability to travel to corporate headquarters as well as attend EU meetings as required
This role provides hybrid working from home and a Central London office, and a strong culture with the support and opportunities to progress further into your career. Alongside this, my client also offers a comprehensive benefits package, including a generous bonus scheme, LTI s, healthcare, and a car allowance.
My client are able to offer visa sponsorship and relocation support to candidates with relevant capabilities.
If you have the skills required and would like to discuss the full details of the job, please contact Katie Dunbar on 952176, or apply with your CV.
About RBW Consulting