Regulatory Affairs Manager in Luton

Role Overview:

Manage all required regulatory procedures for EU and UK products, including both internally developed and in-licensed products. Define appropriate regulatory strategies for submission and approval of new products in the EU and UK, providing guidance to R&D during development. Ensure post-marketing lifecycle management, including identification and submission of variations following Marketing Authorisation (MA) approvals. Oversee regulatory activities for Drug–Device Combinations and Medical Devices in line with EU MDR requirements, including submissions to and approvals from Notified Bodies. Liaise effectively with EU Regulatory Authorities and the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure timely approvals, product launches, and ongoing compliance with regulatory and business requirements. Ensure EU and UK product labelling is compliant and aligned with MA approvals. Develop and implement procedures and processes to maintain regulatory compliance across the EU and UK product portfolio.

Key Responsibilities:

• Regulatory Strategy & Submissions (35%)
  • Act as the regulatory expert to define and execute strategies for submission of registration dossiers in the EU and UK.
  • Maximise the likelihood of rapid Marketing Authorisation approvals.
  • Collaborate closely with global teams (e.g. India-based functions).
  • Lead Scientific Advice activities with regulatory agencies where appropriate.
  • Provide guidance to R&D, including reference product identification.
  • Define and manage variation strategies to ensure business continuity.
  • Support and manage in-licensed product activities.
• Dossier Preparation & Lifecycle Management (20%)
  • Prepare Module 1 (M1) and manage submission of new product applications, post-approval variations and notifications.
  • Coordinate product information and labelling, including leaflet and artwork development.
• Medical Devices & EU MDR Compliance (20%)
  • Ensure full compliance with EU Medical Device Regulation (MDR) requirements.
  • Manage regulatory activities for medical devices and drug–device combination products.
• Regulatory Authority Engagement (10%)
  • Build and maintain strong relationships with EU and UK regulatory authorities.
  • Lead communications via meetings, correspondence, and teleconferences.
  • Prepare responses to regulatory queries and deficiency letters.
  • Develop briefing documents and support materials for agency interactions.
• Compliance & Systems (5%)
  • Ensure adherence to internal SOPs.
  • Maintain regulatory trackers, databases, and documentation systems.
• Cross-Functional Collaboration (10%)
  • Work closely with Commercial and other internal stakeholders.
  • Provide regulatory input, identify opportunities, and communicate risks.

Key Interfaces:

External: EU Regulatory Authorities and the Medicines and Healthcare products Regulatory Agency (MHRA), Notified Bodies, Trade Associations, Customers’ and suppliers’ regulatory departments, Regulatory consultants.

Internal: Regulatory Affairs teams (EU and global), Research & Development, Business Development, Project Management, Pharmacovigilance / Quality Assurance / Supply Chain / Manufacturing, Analytical and Technical teams, Commercial teams.

Work Generation: Self-generated: 70%, Manager-led: 15%, Peer-driven: 15%.

Skills & Experience:

Education: Degree in a scientific discipline (essential), Additional regulatory qualifications (desirable).

Experience: 5–10 years’ experience in Regulatory Affairs within the pharmaceutical industry, Strong knowledge of EU and UK regulatory frameworks and EU MDR, Experience within a generic pharmaceutical environment, Familiarity with decentralised, mutual recognition, and national procedures.

Skills: Broad understanding of regulatory requirements across multiple markets, Experience with electronic submission systems (eCTD), Strong project management and organisational skills, Proficiency with regulatory IT systems.

Personal Attributes: High attention to detail and strong organisational skills, Effective written and verbal communication, Ability to influence and collaborate across teams, Analytical thinking and problem-solving capability, Fluent in English; additional languages are advantageous.