Job Description
Apsida Life Science is partnering with a global CRO company to present the following role: We are seeking an experienced Regulatory Project Manager to support the regulatory management of a portfolio of pharmaceutical products across the product lifecycle in the UK and Ireland. Key Responsibilities - Manage the regulatory delivery and maintenance of clinical assets and Marketing Authorisations (MAs) across an assigned portfolio of products in the UK and Ireland. - Act as a key interface with UK and Irish regulatory authorities, coordinating regulatory communications, meetings, submissions, responses and commitments. - Develop and implement effective regulatory strategies across the product lifecycle, providing proactive regulatory advice and identifying potential regulatory risks and opportunities. - Ensure product information, SmPCs, PILs and labelling remain compliant with approved Marketing Authorisations and applicable regulatory requirements. - Coordinate national input into responses to regulatory authority questions,



requests for information and regulatory commitments, ensuring alignment with regulatory strategy and agreed timelines. - Manage regulatory documentation, product registration information, agency correspondence and records within relevant regulatory databases and repositories. - Coordinate the appropriate and timely notification of product quality and safety issues to regulatory authorities in accordance with company procedures. - Complete Marketing Authorisation Holder (MAH) reviews of Periodic Quality Reviews (PQRs) for applicable products where the Irish affiliate acts as MAH. - Plan and coordinate regulatory activities across the portfolio, ensuring projects are appropriately prioritised, risks are identified early and milestones are delivered on time. - Build solid relationships with Regulatory, Medical, Safety, Clinical, Commercial, Supply Chain and other cross-functional teams, providing regulatory leadership and contributi

📌 Regulatory Project Manager (Mumbai)
🏢 Apsida Life Science
📍 Mumbai