Manager
Regulatory Affairs (EU/UK)

About the Role

As Manager – Regulatory Affairs (EU/UK), you will own the regulatory strategy and dossier management for Bioplus products registered or under registration with the MHRA and EMA. You will work directly with our R&D, QA, and manufacturing teams to ensure our product portfolio meets all EU and UK regulatory requirements, from initial CTA filings through post-authorisation lifecycle management.

This is a senior individual contributor and team lead role — you will manage a small RA team and serve as the primary point of contact for MHRA interactions, including inspection readiness and deficiency responses.

Key Responsibilities

• Lead preparation and submission of CTAs, MAAs, CEPs, and DMFs to MHRA, EMA, and other European competent authorities in eCTD format
• Manage product lifecycle activities including Type I/II variations, renewals, label updates, and annual product reviews for the EU/UK portfolio
• Develop and own the regulatory strategy for new product introductions, line extensions, and reformulations targeting UK and EU markets
• Serve as primary liaison with MHRA assessors during product assessments, providing timely and complete responses to regulatory queries and deficiency letters
• Coordinate across R&D, QA, and Manufacturing teams for dossier preparation, ensuring CTD Module 3 content is accurate, complete, and compliant
• Review and approve UK/EU labelling (PIL, SmPC, outer/inner packaging) in accordance with MHRA/EMA guidelines
• Maintain regulatory intelligence — monitor and implement updates from EMA, MHRA, ICH, and EU Directives/Regulations relevant to Bioplus products
• Lead or support regulatory inspections (MHRA, TGA, EU GMP audits) and preparation activities
• Manage external regulatory consultants and CROs engaged for EU/UK submissions

Qualifications & Experience

• B.Pharm or M.Pharm with specialisation or post-graduate training in Regulatory Affairs; TOPRA or RAC certification advantageous
• 6–10 years in pharmaceutical Regulatory Affairs, with a minimum of 4 years focused on EU and/or UK market submissions
• Proven track record of successful MHRA or EMA product authorisations (MAA or CTA); strong understanding of the MRP/DCP procedures
• Expert knowledge of CTD format, ICH guidelines (M4, Q8–Q12, E-series), and EU Directive 2001/83/EC and UK retained law equivalent
• Experience with eCTD publishing tools — Lorenz DOCUBRIDGE, Veeva Vault RIM, or equivalent
• Strong technical writing and scientific communication skills in English; ability to draft and critically review Module 2 overviews and summaries
• Experience with CMC regulatory affairs for small molecule API and formulated products is essential
• Experience managing direct reports or cross-functional regulatory teams preferred