About this role
Reporting to Regulatory Manager, Oncology UK/ Ireland scopeHybrid-office based in Maidenhead (Tues, Wed, Thurs)Excellent career opportunities for UK and European positions in AbbVieJob 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 practiceKey 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 appropriateRegulatory 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
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 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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