Regulatory Affairs Specialist – MSD

Are you ready to take your pharmaceutical career to the next level with a premier Regulatory Affairs Specialist Job? We are a leading global life sciences recruitment consultancy, currently hiring on behalf of our client, MSD (Merck Sharp & Dohme), one of the world’s largest and most innovative biopharmaceutical organizations. Located in Greater London, this full-time role offers an immersive opportunity to champion local regulatory strategy, navigate changing legal frameworks, and support breakthrough therapies entering the UK market.

Role Overview

Joining MSD means embedding yourself within a global network that operates on the cutting edge of medicine, oncology, and vaccine development. This Regulatory Affairs Specialist Job is designed for a meticulous professional capable of undertaking diverse regulatory activities under guided supervision. You will have a direct hand in managing product lifecycles and ensuring compliance with national guidelines, allowing lifesaving treatments to seamlessly reach patients across the United Kingdom.

Key Responsibilities

1. Strategic Filings: Contributing to critical regulatory filing activities, including scientific advice, Paediatric Investigational Plans (PIPs), and orphan designations for new marketing authorisations (MAs).

2. Lifecycle Management: Maintaining existing product portfolios by coordinating timely submissions of variations, renewal applications, and line extensions.

3. Agency Liaison: Leading communication, alignment, and direct negotiations with the Medicines and Healthcare products Regulatory Agency (MHRA).

4. Compliance & Labelling: Managing artwork, patient information leaflets (PILs), and prescribing info to maintain strict compliance with current legislation.

5. Cross-Functional Collaboration: Representing the regulatory affairs department during product launches and cross-departmental alignment briefings.

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Qualifications & Requirements

1. A BSc degree or higher in pharmacy, life sciences, or a closely related discipline.

2. Previous exposure to a regulatory affairs department or experience within the broader pharmaceutical sector (medical, laboratory, or clinical trials).

3. Strong organizational, planning, and meticulous attention to detail.

4. Exceptional verbal and written communication skills to handle complex data and agency interactions.