Senior Manager, Regulatory Affairs

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas—immunology, oncology, neuroscience, and eye care— and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Work independently, inform Line Manager;

• Acts as the primary Regulatory contact for identified therapeutic area of responsibility.
• Provides line management responsibility for a small team within UK Regulatory Affairs, including recruitment, goal setting, performance appraisal and talent development.
• Oversees all regulatory activities within therapeutic area of responsibility, including maintaining licensing whilst contributing to the Brand Team priorities.
• Uses experience and knowledge of the regulatory landscape to guide team to develop robust regulatory strategies and timely submissions to the Medicines and Healthcare Products Agency (MHRA), ensuring the fastest approvals, implementations and product launches.
• Develops and maintains relationships with Area & Affiliate members of GRS Europe and cross functional partners to share knowledge, increase regulatory awareness and build networks.
• Engages externally with the Health Authority on regulatory submissions and/or other pharmaceutical industry trade associations, as required.
• Supports the business in planning for and execution of product launches, acquisitions and divestitures, as required.

• Provides clear guidance and recommendations on UK regulatory strategies and tactical plans throughout a product lifecycle including clinical trial submissions, management of variations, paediatric investigation plans, new marketing authorisation applications and liaison with local regulatory authorities.
• Reviews regulatory submissions for UKRA team for assigned areas of responsibility, corrects where necessary and provides feedback.
• Regulatory intelligence and external landscape monitoring,
  • Interacts with Regulatory policy makers and professional associations (eg ABPI) to gather knowledge about trends, future changes and current landscape in accordance with the national and EU legislation and relevant Associations’ Codes and advocate for Abb Vie’s interests.

• Ensures compliance with Abb Vie’s policies and procedures to meet statutory, quality and business requirements, acting as primary point of regulatory contact for audits and inspections in the UK as appropriate and supporting oversight of divisional policies and procedures.
• Ensures compliance with UK legislation for Medicines, Medical Devices, clinical trials and paediatric investigation plans and has an awareness of the ABPI code.

• Acts as Regulatory liaison with Area and local UK cross functional teams to ensure UK strategies align with global strategies, whilst maintaining compliance with local regulations.
  • Understand and articulate the regulatory perspective across the business, translating key regulatory decisions in terms of impact on products in the UK.
• Acts as lead Regulatory representative on Affiliate committees/initiatives (as required).
• Acts as deputy to the UK Regulatory Affairs Managers and/or Director (as required).

• Provides strong leadership and direction to the UK Regulatory Therapeutic Regulatory team to support:
  • Successful implementation of regulatory product strategies
  • Develops and maintains strong working relationships with MHRA and local pharmaceutical company trade associations
  • Process improvements, internal compliance and team consistency
  • Individual professional development, improved capability and upskilling within team
  • Supports recruitment activities (as required) and retain high calibre regulatory affairs professionals

To comply with the company’s policies and procedures to…