Regulatory Affairs Manager

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

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