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