Job Summary
Under the supervision of line management or guidance from an experienced Senior Regulatory Manager, conduct agreed strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs.
Job Responsibilities
•Deliver Regulatory Strategy and Advise Cross-Functional Teams
•Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.
•Manage New Registration/Marketing Authorization Applications
•Manage Marketing Authorization (MA) Variation Applications
•Manage MA Renewal Applications
•Management of NRA queries
•Develop knowledge of NRA's expectations, ways of working etc. to inform assigned product regulatory strategies. Share updates and regulatory intelligence with colleagues.
•Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.
•Respond to spontaneous requests from authorities promptly and accurately.
•Support the strategic clinical development activities in partnership with national Regulatory Authorities, Above Country Regulatory Strategists and Clinical Trials Regulatory Strategy Execution (CTRSE) as applicable.
•Populate and Maintain Regulatory Databases
•Obtain NRA Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use)
•Safeguard Compliance in the Management of Packaging and Prescribing Information Component updates
•Support MA Divestments, MA Cancellations, product Discontinuations and Supply Continuity
•Support Third Party Licenses
•Support regulatory activities for the development and maintenance of medical devices if required.
•Contribute to Good Regulatory Practice (GRP)
•Support Regulatory Group Development
•Lead Personal Development
Qualifications / Skills
•Life sciences or chemistry graduate to honors level or equivalent
•Master's degree, Post Graduate Diploma or PhD preferred
•Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory)
•Previous experience and proven track record in Regulatory (Human Medicinal Products) in UK & Ireland
•Computer literacy
•Excellent written and verbal communication skills
•Proven strength in analytical thinking
All applicants must have the relevant authorization to live and work in the UK.
