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Regulatory Affairs Manager
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The Senior Regulatory Affairs Manager is responsible for providing strategic regulatory support to the UK and global organisations. This includes submission, approval, and life-cycle management of assigned Marketing Authorisations (MAs). The successful candidate will also act as a mentor for Regulatory Affairs Managers and contribute to the continuous process improvements and inspection readiness for both internal process reviews/audits and HA inspections for GxP.
Key Responsibilities- Develop and implement regulatory strategies to ensure compliance with medicines legislation and guidelines.
- Provide regulatory advice to global and UK business on all aspects of maintenance work, including data requirements, strategy, and medicines legislation.
- Contribute to regulatory strategy by participation in RA Subteams and provide assistance to the global RA representative as appropriate.
- Manage new MA submissions, including Scientific Advice meetings, attendance at launch meetings, pre-vetting materials, and stock readiness.
- Independently manage official local drug information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs, and their Educational Material.
- Work closely and swiftly with cross-functional teams to address critical issues, such as batch recall or other batch release issues.
- Life Science Degree or other relevant education.
- Broad range of regulatory experience, encompassing CMC, Clinical, and Commercial aspects in the ethical pharmaceutical industry.
Why Novartis: At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We are a global healthcare leader dedicated to discovering new medicines that improve and extend people's lives.
Join our Novartis Network: If you are passionate about regulatory affairs and want to be part of a dynamic team, we encourage you to apply for this exciting opportunity. As a member of our team, you will have the chance to work on challenging projects, develop your skills, and contribute to the success of our organisation.