Associate Director Regulatory Affairs

We are supporting a fast-growing, entrepreneurial pharmaceutical company in its search for a Senior Regulatory Specialist to take ownership of regulatory strategy and lifecycle management across its portfolio.

This is a senior-level opportunity for an experienced Regulatory Affairs professional who has operated with a high degree of autonomy and decision-making responsibility throughout the post-approval lifecycle, including new product registrations, CMC regulatory strategy, MAH obligations, and regulatory submissions across the UK and EU.

Key Responsibilities:

• Own regulatory strategy and submissions across the product portfolio

• Manage post-approval lifecycle activities, including variations, renewals and line extensions

• Oversee MAH and PV compliance, including PSMF/QPPV arrangements, safety reporting and RMP commitments

• Lead regulatory strategy for new Marketing Authorisation applications and line extensions

• Define regulatory pathways across UK and EU markets

• Plan and oversee dossier preparation, submission and health authority interactions

• Review and approve CMC regulatory content, including manufacturing changes and comparability considerations

• Oversee packaging, labelling and artwork updates

• Manage external regulatory consultants, contractors and specialist partners

• Lead and develop the regulatory team while ensuring high-quality, compliant submissions

• Manage the regulatory budget, forecasting and external spend

About You:

• Strong experience in pharmaceutical Regulatory Affairs with proven ownership of regulatory activities across a portfolio of medicinal products

• Demonstrable experience with variations, renewals and new Marketing Authorisation applications

• Experience with dossier planning, submission management, LoQ responses and health authority engagement

• Strong CMC regulatory experience, including manufacturing changes and comparability considerations

• Experience with MAH responsibilities and a good understanding of PV, PSMF and QPPV requirements

• Experience managing internal teams, external consultants or regulatory partners

• Experience managing regulatory budgets and external regulatory spend

• Good knowledge of UK and EU regulatory frameworks

• Experience working in a small or mid-sized pharmaceutical environment is highly desirable

• Able to operate independently, make strategic regulatory decisions and take ownership of complex regulatory matters

• Comfortable working in a hybrid environment with 3 days per week in the office

Senior Regulatory Affairs / Regulatory Affairs / Pharma / Lifecycle Management / Variations / New Marketing Authorisations / CMC / MAH / PV / PSMF / QPPV / eCTD / MHRA / EMA / EU Regulatory Affairs / UK Regulatory Affairs / DCP / MRP / Line Extensions / Health Authority / Pharmaceutical / London/113786