Regulatory Affairs Senior Manager, Regional CoE

LCM Portfolio Leadership: Lead the regional Life Cycle Management portfolio, ensuring alignment with business priorities, agreed service levels, and quality and compliance expectations. Demand and Resource Management: Manage intake, prioritization, work allocation, capacity visibility, and governance of activities transferred from Marketing Company teams. Operational Strategy and Regulatory Execution: Lead complex or high-impact activities related to dossier customization, regulatory submissions, national requirements, post-approval pathways, and CMC change management. Dossier Preparation: Ensure the preparation, compilation, and quality review of country-ready regulatory packages, including Module 1, national forms, cover letters, declarations, local administrative documentation, translations, and ERV activities where applicable. Submissions and Tracking: Execute or support regulatory submissions under the agreed operating model, maintain submission evidence, and ensure regulatory records remain complete and current.

Education

University degree or equivalent professional qualification in Pharmacy, Science, Chemistry, Biology, Engineering, or a related discipline. Regulatory

Experience

Minimum 7 years of extensive experience in regulatory affairs for biopharmaceutical products, including significant responsibility for Life Cycle Management of assigned products, national submissions, labeling, and regulatory CMC activities. Multinational

Experience

Experience working across multiple markets, products, and national regulatory requirements within a regional or international environment. Technical Knowledge: Strong understanding of post-approval regulatory frameworks, national dossier requirements, health authority procedures, CMC change management, and implementation controls. Portfolio Leadership: Demonstrated experience leading complex regulatory portfolios and cross-functional matrix teams. Stakeholder Management: Ability to collaborate, influence, negotiate, and align local, regional, and global teams, as well as technical and functional partners. Communication: Excellent written and verbal communication skills in English, with the ability to present technical information, risks, alternatives, and recommendations to senior stakeholders. Autonomy and Professional Judgment: Ability to make operational decisions, set priorities, and manage complex or ambiguous situations with a high degree of autonomy. Scientific and Regulatory Judgment: Ability to evaluate technical and regulatory information, identify gaps, and provide practical, evidence-based recommendations. Systems and Data Management: Experience using regulatory information systems, records management tools, submission tracking systems, and regulatory data maintenance processes. Desirable Capabilities Experience leading Centres of Excellence, regional hubs, shared services models, or transformation programs. Experience with Veeva RIM, ERV, or other regulatory planning, analytics, and management platforms. Experience implementing automation, digital workflows, dashboards, or continuous improvement solutions. Experience working with small molecules, biologics, or biotechnology-derived products. Experience partnering with Manufacturing, Supply, Quality, Labelling, and other functions involved in post-approval change implementation.