Senior Regulatory Affairs Manager

Novartis; London; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Senior Regulatory Affairs Manager to oversee the submission and approval process for Marketing Authorisations. This hybrid role includes mentoring team members and providing strategic regulatory advice to ensure compliance and expedite submission outcomes. The ideal candidate will hold a Life Science Degree and have substantial regulatory experience across various aspects of the pharmaceutical industry.

Qualifications

• Broad regulatory experience covering CMC, Clinical, and Commercial aspects.
• Life Science Degree or equivalent education.
• Experience in ethical pharmaceutical industry desired.

Responsibilities

• Managing submissions and approvals for Marketing Authorisations.
• Advising on regulatory strategy and data requirements.
• Critically evaluating submission packages for compliance.

Skills

Clinical Trials

Detail-Oriented

Drug Development

Lifesciences

Negotiation Skills

Regulatory Compliance

Education

Life Science Degree

Job description

Job Description 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 organizations. They also act as a mentor for Regulatory Affairs Managers.

This is a hybrid role - there is a requirement of a minimum of three days on-site in the London office.

Job Description

Major Accountabilities

Responsibilities for a number of MAs, including:

• Working closely with global and local colleagues to advise on and agree upon regulatory strategy and data requirements.
• Critically evaluating submission packages to ensure compliance with regulatory requirements, eliminating deficiencies before submission within agreed timeframes.
• Monitoring and influencing assessment processes to expedite and optimize submission outcomes, including negotiations with MHRA for optimal labelling, supply continuity, and delivery of commitments and deadlines.
• Communicating regulatory changes to the business to support license compliance.
• Collaborating with cross-functional teams to address critical issues such as batch recalls or release issues.
• Managing submission and maintenance of official local drug information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs, and educational materials.
• Managing new MA submissions independently, including Scientific Advice meetings, launch meetings, pre-vetting, and stock readiness.

Customer

• Providing regulatory advice to global and UK teams on maintenance activities, data requirements, strategy, and legislation to support informed decision-making and optimal assessment outcomes.
• Participating in RA Subteams to contribute to regulatory strategy and supporting global RA representatives.
• Offering regulatory support for divestment and in-licensing opportunities.
• Building and maintaining relationships with MHRA and internal teams to meet business needs.
• Participating actively in Business franchise meetings to provide regulatory insights and support.

People

• Mentoring Regulatory Affairs Managers and deputising for the Regulatory Affairs Business Franchise Lead when needed.
• Coaching less experienced team members and contributing to process improvements and inspection readiness for internal audits and GxP inspections.
• Engaging in personal development initiatives.

Minimum Requirements

• A Life Science Degree or relevant educational background.
• Broad regulatory experience covering CMC, Clinical, and Commercial aspects in the ethical pharmaceutical industry.

Languages

• English

Skills Desired

Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance