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: (Percentages indicate approximate time allocation and total 100%)
1. 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.
2. 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.
3. 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.
4. 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.
5. Compliance & Systems (5%)
- Ensure adherence to internal SOPs.
- Maintain regulatory trackers, databases, and documentation systems.
6. 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