Senior Project Manager, Regulatory Affairs - Oncology

• Reporting to Regulatory Manager, Oncology  
• UK/ Ireland scope
• Hybrid-office based in Maidenhead (Tues, Wed, Thurs)
• Excellent career opportunities for UK and European positions in AbbVie

Job Overview

• Acts as the primary Regulatory contact for UK Oncology
• Supports lifecycle management of applicable products, management of paediatric investigation plans and clinical trial activities with the Medicines and Healthcare Products Regulatory Agency (MHRA)
• Develops regulatory strategies and updates to cross functional team
• Maintains relationships with Area Regulatory team to advocate the UK strategy objectives and timelines
• Serves as Health Authority liaison and interface for Health Authority meetings to obtain optimal outcomes for patients and AbbVie’s portfolio
• Supports the business in planning for and execution of product launches, acquisitions and divestitures, as required
• Regulatory intelligence and external landscape monitoring – provides regulatory impact assessment and establishes best practice

Key Responsibilities

Regulatory Strategy and Tactical Implementation

1. Acts as an interface between the Area and Brand teams
2. Ensures submission and content of new Marketing Authorisations, variations and other regulatory submissions, paediatric investigation plans and clinical trials are made in accordance with appropriate timings and requirements and maintains appropriate tracking of the process as applicable
3. Supports the conduct technical assessments
4. Reviews regulatory submissions for UKRA team for assigned areas of responsibility, corrects where necessary and provides feedback, as required
5. Monitors regulatory intelligence and external landscape for identified portfolio/area of responsibility and cascades information, as appropriate

Regulatory Compliance

1. Ensures adherence to AbbVie’s policies and procedures to meet statutory, quality and business requirements. Acts as a regulatory contact for audits and inspections in the UK as appropriate and has oversight of divisional policies and procedures
2. Ensures compliance with UK legislation for Medicines, Medical Devices, clinical trials and paediatric investigation plans and has an awareness of the ABPI code
3. Act 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
4. Understand and articulate the regulatory perspective across the business, translating key regulatory decisions in terms of impact on products in the UK
5. Acts as deputy to the UK Regulatory leader on committees/initiatives as required.

Leadership for UK Regulatory Therapeutic portfolio

1. Provides strong leadership for identified portfolio support:
2. Successful implementation of regulatory product strategies.
3. Develops and maintains strong working relationships with MHRA.

Qualifications

• Regulatory professional with relevant experience in the pharmaceutical industry with a clear understanding of the UK regulatory submissions process
• Strong diplomacy, influencing and presentation skills
• Consultative and collaborative interpersonal style
• Excellent written, verbal and interpersonal skills
• Ability to work effectively and collaboratively across cultures and cross-functionally
• Ability to identify compliance risks and escalate when necessary
• Life Sciences Degree in relevant subject area is preferred

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. 

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