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, Sm PCs, 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 contributing to effective business solutio

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