Regulatory Affairs Manager
il y a 3 jours
Watford
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 Affairs teams (EU and global), • Research & Development, • Business Development, • Project Management, • Pharmacovigilance / Quality Assurance / Supply Chain / Manufacturing, • Analytical and Technical teams, • Self-generated: 70%, • Manager-led: 15%, • Peer-driven: 15% Skills & Experience: Education • Degree in a scientific discipline (essential), • 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, • Broad understanding of regulatory requirements across multiple markets, • Experience with electronic submission systems (eCTD), • Strong project management and organisational skills, • 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