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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description
Reporting to Regulatory Manager, Oncology  UK/ Ireland scopeHybrid-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 OncologySupports 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 teamMaintains relationships with Area Regulatory team to advocate the UK strategy objectives and timelinesServes as Health Authority liaison and interface for Health Authority meetings to obtain optimal outcomes for patients and AbbVie’s portfolioSupports the business in planning for and execution of product launches, acquisitions and divestitures, as requiredRegulatory intelligence and external landscape monitoring – provides regulatory impact assessment and establishes best practice

Key Responsibilities

Regulatory Strategy and Tactical Implementation

Acts as an interface between the Area and Brand teamsEnsures 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 applicableSupports the conduct technical assessmentsReviews regulatory submissions for UKRA team for assigned areas of responsibility, corrects where necessary and provides feedback, as requiredMonitors regulatory intelligence and external landscape for identified portfolio/area of responsibility and cascades information, as appropriate

Regulatory Compliance

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 proceduresEnsures compliance with UK legislation for Medicines, Medical Devices, clinical trials and paediatric investigation plans and has an awareness of the ABPI codeAct as Regulatory liaison with Area and local UK cross functional teams to ensure UK strategies align with global strategies, whilst maintaining compliance with local regulationsUnderstand and articulate the regulatory perspective across the business, translating key regulatory decisions in terms of impact on products in the UKActs as deputy to the UK Regulatory leader on committees/initiatives as required.

Leadership for UK Regulatory Therapeutic portfolio

 

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

Qualifications

Regulatory professional with relevant experience in the pharmaceutical industry with a clear understanding of the UK regulatory submissions processStrong diplomacy, influencing and presentation skillsConsultative and collaborative interpersonal styleExcellent written, verbal and interpersonal skillsAbility to work effectively and collaboratively across cultures and cross-functionallyAbility to identify compliance risks and escalate when necessaryLife Sciences Degree in relevant subject area is preferred
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, visit https://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