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Regulatory Affairs Manager

2 months ago


London, Greater London, United Kingdom Novartis Farmacéutica Full time
About the Role

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.
Requirements
  • 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.