Regulatory Affairs Specialist - Pharmaceuticals

Pharmaceutical Regulatory Affairs Specialist 40k - 45k Hertfordshire PermanentAre 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 ..... full job details .....