Job Opportunities API

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.