Regulatory Project Manager

Apsida Life Science · India

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 strong relationships with Regulatory, Medical, Safety, Clinical, Commercial, Supply Chain and other cross-functional teams , providing regulatory leadership and contributing to effective business solutions.

Experience

• Strong practical experience within Pharmaceutical Regulatory Affairs , ideally covering UK and/or EU regulatory environments.
• In-depth understanding of UK, Irish and/or EU regulations, guidelines and regulatory practices .
• Experience managing products across the full regulatory lifecycle , including registrations, maintenance activities and post-approval changes.
• Experience interacting with national and/or European regulatory authorities .
• Good understanding of the drug development and regulatory submission process .
• Experience coordinating regulatory projects involving multiple internal stakeholders.
• Understanding of regulatory requirements relating to product information, SmPCs, PILs and labelling .
• Experience managing regulatory commitments, authority questions and regulatory correspondence.
• Understanding of quality, safety and medical regulatory requirements relevant to pharmaceutical products.

If you are interested in learning more, please reach out to Mufaro Mpofu at Apsida Life Science:

mufaro.mpofu@apsida.com

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process