Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs

AbbVie

Maidenhead, United Kingdom

Job Description

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 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.

MAIN ACCOUNTABILITIES

Regulatory Strategy and Tactical Implementation:

• 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 AbbVie’s interests.

Regulatory Compliance:

• Ensures compliance with AbbVie’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.

Liaison with Internal Stakeholders:

• 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).

Leadership for UK Regulatory Therapeutic team:

• 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

GENERAL ACCOUNTABILITIES

To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie Ltd.

Responsible for the health, safety and environmental performance of themselves and others through compliance within EHS programs, regulations and standards. Subject to the policy and procedures outlined in the EHS Handbook.

Qualifications:

• Experienced Regulatory professional in the pharmaceutical industry with a clear understanding of the UK regulatory and submissions process
• Experience as a line manager with highly developed people skills
• Sense of personal responsibility and accountability, with a positive, can-do attitude
• Ability to multitask, prioritise, and manage multiple projects and deadlines
• Ability to work effectively and collaboratively across cultures and cross-functionally
• Strong diplomacy, influencing, presentation skills
• Consultative and collaborative interpersonal style
• Excellent written, verbal and interpersonal skills (in English)
• Ability to identify compliance risks and escalate when necessary
• Life Sciences Degree in relevant subject area
• Computer literate