7360-Janssen-Cilag Limited Legal Entity
High Wycombe, Buckinghamshire
Overview Johnson & Johnson is a global healthcare company dedicated to innovative medicine and medical devices. This role is for a Manager Global Regulatory Scientist within Regulatory Affairs. The position is hybrid and available in Beerse, Belgium; Leiden, Netherlands; High Wycombe/Maidenhead, UK; or Raritan, NJ and Spring House, PA (USA). Responsibilities Draft cover letters and support the preparation of regulatory submissions and related documents for IND, CTA, MAA/NDA and eCTD submissions. For CTA/INDs, ensure protocols align with regulatory requirements and advise on required documents and submission strategies. Provide regulatory support throughout the registration process for Marketing Authorizations (NDA, MAA, etc.). Advise on required documents and submission strategies in NDA/MAA filings (in collaboration with local operating centers as appropriate). Assist with timely NDA/MAA availability and ensure document components are in place on time; identify and track critical path activities. Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, and others); prepare country-specific submission packages for LOCs. Assist in the preparation of meetings with Regulatory Agencies and coordinate content for responses to queries from Health Authorities to ensure high quality, timely responses. Act as backup contact on multi-discipline teams or with regulatory agencies as needed; may organize and lead meetings. Provide regulatory input for inspections, audits, litigation support, and product complaints. Support GRL/GRT by driving high-level project management for global submissions and Health Authority interactions. Participate in global regulatory team meetings and assist in strategy development by researching regulatory and medical information for submissions. Advise the Regulatory team on applicable regulatory requirements and project-specific issues; partner with regulatory colleagues to understand the competitive landscape and labeling differences. Assist in the development and improvement of regulatory processes. Qualifications Bachelor's degree in a scientific or equivalent discipline; advanced scientific degree preferred. Minimum of 4 years in health-regulated industry experience (or Master's with 5 years; PhD/PharmD with 4 years). At least 4 years of relevant regulatory affairs experience in pharmaceutical/biotech industry. Knowledge of multiple global health authorities' regulations and processes; solid understanding of FDA and ICH requirements related to clinical research, product development, life-cycle submissions, and labeling. Therapeutic area experience in oncology is beneficial. Experience with combination products (drug and device) is an asset. Strong curiosity and ability to learn new areas with limited regulatory precedence; ability to work across different product types (pharma, devices, combo products). Experience preparing responses to Health Authorities and managing Health Authority interactions and lifecycle management of trials and marketing authorizations (IND/CTA, NDA/MAA, BLA, etc.). Experience in strategic planning, technical data summaries, and cross-functional management. Leadership capabilities: strong organizational and time management, collaboration, conflict resolution, and ability to work in a matrixed environment. Strong critical thinking, problem-solving, and strategic planning skills. Willingness to travel (approximately 10% domestic; international travel may be required).
Overview Johnson & Johnson is a global healthcare company dedicated to innovative medicine and medical devices. This role is for a Manager Global Regulatory Scientist within Regulatory Affairs. The position is hybrid and available in Beerse, Belgium; Leiden, Netherlands; High Wycombe/Maidenhead, UK; or Raritan, NJ and Spring House, PA (USA). Responsibilities Draft cover letters and support the preparation of regulatory submissions and related documents for IND, CTA, MAA/NDA and eCTD submissions. For CTA/INDs, ensure protocols align with regulatory requirements and advise on required documents and submission strategies. Provide regulatory support throughout the registration process for Marketing Authorizations (NDA, MAA, etc.). Advise on required documents and submission strategies in NDA/MAA filings (in collaboration with local operating centers as appropriate). Assist with timely NDA/MAA availability and ensure document components are in place on time; identify and track critical path activities. Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, and others); prepare country-specific submission packages for LOCs. Assist in the preparation of meetings with Regulatory Agencies and coordinate content for responses to queries from Health Authorities to ensure high quality, timely responses. Act as backup contact on multi-discipline teams or with regulatory agencies as needed; may organize and lead meetings. Provide regulatory input for inspections, audits, litigation support, and product complaints. Support GRL/GRT by driving high-level project management for global submissions and Health Authority interactions. Participate in global regulatory team meetings and assist in strategy development by researching regulatory and medical information for submissions. Advise the Regulatory team on applicable regulatory requirements and project-specific issues; partner with regulatory colleagues to understand the competitive landscape and labeling differences. Assist in the development and improvement of regulatory processes. Qualifications Bachelor's degree in a scientific or equivalent discipline; advanced scientific degree preferred. Minimum of 4 years in health-regulated industry experience (or Master's with 5 years; PhD/PharmD with 4 years). At least 4 years of relevant regulatory affairs experience in pharmaceutical/biotech industry. Knowledge of multiple global health authorities' regulations and processes; solid understanding of FDA and ICH requirements related to clinical research, product development, life-cycle submissions, and labeling. Therapeutic area experience in oncology is beneficial. Experience with combination products (drug and device) is an asset. Strong curiosity and ability to learn new areas with limited regulatory precedence; ability to work across different product types (pharma, devices, combo products). Experience preparing responses to Health Authorities and managing Health Authority interactions and lifecycle management of trials and marketing authorizations (IND/CTA, NDA/MAA, BLA, etc.). Experience in strategic planning, technical data summaries, and cross-functional management. Leadership capabilities: strong organizational and time management, collaboration, conflict resolution, and ability to work in a matrixed environment. Strong critical thinking, problem-solving, and strategic planning skills. Willingness to travel (approximately 10% domestic; international travel may be required).