Regulatory Affairs Specialist - Pharmaceuticals

Pharmaceutical Regulatory Affairs Specialist | £40k - £45k | Hertfordshire | Permanent

Are you a Regulatory Affairs professional with a sharp eye for compliance and a passion for guiding pharmaceutical products through every stage of their lifecycle?

Smart4 Sciences are working with a pharmaceutical manufacturing company that's looking for an experienced Regulatory Affairs Specialist to join their team. This is an exciting opportunity to play a vital role in ensuring the company's products meet UK and EU regulatory standards from early development through post-marketing.

Whether you're preparing submissions or staying ahead of evolving MHRA/EMA guidelines, this is a key position with real influence and variety.

The Role:

As Pharmaceutical Regulatory Affairs Specialist, you'll be responsible for:

• Preparing and submitting regulatory dossiers (MAAs, variations, renewals) to health authorities.
• Leading post-marketing activities, including Type IA, IB, II variations, sunset clauses, re-classifications, and gap analyses.
• Reviewing and approving product labelling and packaging for compliance.
• Monitoring and interpreting regulatory changes from the MHRA, EMA, and ICH, and ensuring company-wide alignment.
• Acting as the key liaison with regulatory authorities, managing communications, responses, and inspections.
• Supporting cross-functional teams including Quality, Manufacturing, and Development with regulatory input.
• Contributing to regulatory strategy and lifecycle planning for pharmaceutical products.

What We're Looking For:

• Degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related discipline (advanced degree a bonus).
• Significant experience in Regulatory Affairs within the pharmaceutical industry.
• Solid understanding of EU/UK regulatory frameworks, including MHRA and EMA submissions.
• Strong knowledge of CMC (Chemistry, Manufacturing, and Controls) documentation and requirements.
• Familiarity with eCTD submissions and document management systems.
• A confident communicator who can represent the business to regulators and internal stakeholders alike.

Ready for your next move?

If you're a Regulatory Affairs specialist ready to join a fast-moving, supportive environment with a strong pipeline and clear compliance culture please apply today or contact Gareth Gooley at Smart4 Sciences on