Regulatory Affair Manager

Our client is looking to recruit an RA Manager to join their growing team. The chosen candidate will:

Regulatory Strategy

• Develop and execute regulatory strategies that support product registrations, lifecycle activities, and commercial objectives.
• Provide regulatory guidance for new product launches, variations, renewals, marketing authorisation transfers, and portfolio optimisation initiatives.
• Assess regulatory pathways to facilitate business development opportunities and market expansion.
• Marketing Authorisation Management
• Prepare, review, coordinate, and submit regulatory applications, including:
• Marketing Authorisation Applications (MAAs)
• Variations
• Renewals
• Line Extensions
• Responses to regulatory queries
• National, Mutual Recognition Procedure (MRP), and Decentralised Procedure (DCP) submissions
• Ensure all submissions are completed in accordance with European regulatory requirements and agreed timelines.

Lifecycle Management

• Oversee the regulatory lifecycle of the assigned product portfolio.
• Coordinate the implementation of regulatory commitments and responses to competent authority requests.
• Support artwork and labelling updates arising from regulatory approvals or legislative changes.
• Maintain ongoing compliance of authorised medicinal products with applicable regulatory requirements.
• Regulatory Intelligence
• Monitor developments in European pharmaceutical legislation, regulatory guidelines, and industry requirements.
• Evaluate the impact of regulatory changes on the product portfolio and business activities.
• Provide timely regulatory advice and guidance to internal stakeholders.
• Regulatory Authority Liaison
• Serve as the primary regulatory contact for European competent authorities.
• Coordinate and manage responses to regulatory questions, deficiency letters, and requests for additional information.
• Support regulatory inspections, scientific advice meetings, and other authority interactions as required.

Cross-Functional Collaboration

• Work collaboratively with Quality Assurance, Pharmacovigilance, Supply Chain, Commercial, Technical Services, Manufacturing, and external regulatory consultants to ensure regulatory requirements are effectively integrated into business operations and product lifecycle activities.

Education and Experience

• Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or another relevant scientific discipline.
• A postgraduate qualification in Regulatory Affairs would be considered an advantage.
• Minimum of 6-8 years' experience in Pharmaceutical Regulatory Affairs
• Proven experience managing European regulatory submissions and lifecycle activities with strong working knowledge of: MRP, DCP, Variations, National procedures, renewels, eCTD dossier prep and lifecycle management