Senior Manager, Regulatory Affairs

BioSpace; Maidenhead; Hybrid; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Excellent benefits

Opportunities to progress

Job summary

AbbVie in Maidenhead is seeking a Regulatory leader responsible for the identified therapeutic area. You will oversee a UK Regulatory Affairs team, maintain licensing, and drive strategies for timely MHRA submissions and product launches.

You will build relationships with MHRA, ABPI and cross-functional partners, providing guidance on regulatory decisions and ensuring compliance across the lifecycle of medicines in the UK.

Qualifications

• Experienced Regulatory professional in the pharmaceutical industry with UK submissions knowledge.
• Experience as a line manager with strong people skills.
• Ability to multitask, prioritise, and manage multiple projects and deadlines.
• Strong diplomacy, influencing and presentation skills.
• Excellent written, verbal and interpersonal skills (in English).
• Life Sciences Degree in relevant subject area.

Responsibilities

• Acts as the primary Regulatory contact for the identified therapeutic area.
• Provides line management for a small UK Regulatory Affairs team including recruitment and performance management.
• Oversees regulatory activities including licensing and contributing to Brand Team priorities.
• Guides team on regulatory strategies and timely MHRA submissions for fastest approvals.
• Develops relationships with GRS Europe and cross-functional partners.
• Engages with Health Authority on submissions and industry associations as required.
• Supports planning for product launches, acquisitions and divestitures.

Skills

Regulatory expertise

Line management

Multitasking

Cross-cultural collaboration

Diplomacy & presentation

Written and verbal English proficiency

Interpersonal collaboration

Problem solving

Regulatory strategy knowledge

Education

Life Sciences Degree

Job description

Company Description

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

• Located in Maidenhead (3 days per week Tuesday, Wednesday, Thursday)
• Aligned with Neuroscience business unit
• Excellent benefits and opportunities to progress
  

Job Overview

• Acts as the primary Regulatory contact for identified therapeutic area of responsibility.
• Provides line management responsibility for asmall team within UK Regulatory Affairs, includingrecruitment, 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.
  

Regulatory Strategy and Tactical Implementation

• Provides clear guidance and recommendations on UK regulatory strategies and tactical plans throughout a product lifecycle includingclinical 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 AbbVies interests.
    

Regulatory Compliance

• Ensures compliance with AbbVies 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
    

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
  

Personal Skills

• Consultative and collaborative interpersonal style
• Excellent written, verbal and interpersonal skills (in English)
• Ability to identify compliance risks and escalat ewhen necessary
• Life Sciences Degree in relevant subject area
• Computer literate
  

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html