Senior Regulatory Affairs Manager

This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.

Summary

The Senior Regulatory Affairs Manager is proficient in all aspects of submission, approval and life-cycle management of assigned Marketing Authorisations (MAs), providing effective regulatory support to the UK and global organisations. They also act as a mentor for Regulatory Affairs Managers. This is a hybrid role - there is a requirement of a minimum three days on site in the London office.

About the Role

Major Accountabilities

• Responsibilities for a number of MAs for which the following activities will be required:
• Works closely with global and local colleagues to advise and agree on regulatory strategy and data requirements.
• Critically evaluates submission packages in line with regulatory requirements in order to eliminate deficiencies prior to construction and submission of MA applications within agreed timeframes.
• Monitors and influences assessment process to expedite and optimise the outcome of their submissions.
• Drives negotiations with MHRA to ensure best possible outcome which may include optimal product labelling or assurance of supply continuity and delivery of their commitments and deadlines.
• Ensures communication of any regulatory changes to the business as necessary to support license compliance.
• Works closely and swiftly with cross functional teams to address critical issues eg batch recall or other batch release issues.
• Submission and maintenance of official local drug information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs and their Educational Material.
• Independently manages new MA submissions eg Scientific Advice meetings, attendance at launch meetings, pre-vetting materials and stock readiness.

Customer

• Provides regulatory advice to global and UK business on all aspects of maintenance work including advice on data requirements, strategy, medicines legislation/guidelines, to ensure informed decision making and best chance of optimal assessment timing and outcome.
• Contributes to regulatory strategy, by participation in RA Subteams, providing assistance to the global RA representative as appropriate.
• Provides regulatory advice and support for divestment and in-licensing opportunities.
• Proactively builds relationships externally (MHRA) and internally (BF, MI, TechOps, Patient Safety, Global colleagues), so that business needs are met.
• Active participation in Business franchise meetings providing regulatory advice and support to the UK teams.

People

• Acts as a mentor for Regulatory Affairs Managers and occasionally deputises for Regulatory Affairs Business Franchise Lead.
• Assists in coaching and developing less experienced members of the team (professional/interpersonal skills).
• Contributes to the continuous process improvements and inspection readiness for both internal process reviews/audits and HA inspections for GxP.
• Self initiates personal development opportunities.

Minimum Requirements:

• Life Science Degree or other relevant education.
• Broad range of regulatory experience, encompassing CMC, Clinical and Commercial aspects in the ethical pharmaceutical industry.
• Languages: English.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Benefits and Rewards:

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally.