Vacancy description
Apsida Life Science
India, Mumbai
Regulatory Compliance Project Manager in Mumbai, India is listed on Jobeax. Browse 30,000+ vacancies available.
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 .
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.
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
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