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%)
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.
* Prepare Module 1 (M1) and manage submission of:
o New product applications
o 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
o EU Regulatory Authorities and the Medicines and Healthcare products Regulatory Agency (MHRA)
o Trade Associations
o Customers’ and suppliers’ regulatory departments
o Regulatory consultants
* Internal
o Regulatory Affairs teams (EU and global)
o Research & Development
o Business Development
o Project Management
o Pharmacovigilance / Quality Assurance / Supply Chain / Manufacturing
o Analytical and Technical teams
o Commercial teams
Work Generation
* Self-generated: 70%
* Manager-led: 15%
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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