Regulatory Project Manager

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:

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