AbbVie Therapeutic Area Head (Western Europe), Regulatory, Oncology in Maidenhead, United Kingdom
Therapeutic Area Head (Western Europe), Regulatory, Oncology
United Kingdom, England, Maidenhead
2 additional locations
United KingdomUnited Kingdom, England
Therapeutic AreaHead (Western Europe), Regulatory, Oncology
Based in our Maidenhead offices with up to 30% travel.
Reporting to the Head of Regulatory Affairs, Western Europe.
Competitive salary, long term incentives, car allowance, bonus and comprehensive benefits package.
AbbVie is an ambitious health business where people and quality of life come first. The experience of illness is personal, so we care about the things that matter to patients. As market leader, we team with partners to co-design health solutions around our innovative medicines for complex diseases, which improve standards of care. Helping people to be fit for work and family life is how we make a remarkable impact to the lives of men, women and children.
The core purpose of this role is to support the AbbVie regulatory mission, which is, with a focus on our patients, to design and deliver optimized global regulatory strategies for Western Europe that align with AbbVie’s business strategy. This is an exciting opportunity to head up the Oncology Regulatory Affairs team (consisting of 8 direct reports), in a European Centre of Excellence, in a company with a leading edge pipeline in the oncology space. The role presents an opportunity for ‘cross-cultural’ leadership, interacting regularly with the Global Regulatory function and Area Commercial teams.
Leadsthe assigned Western Europe Regulatory Affairs (WE RA) Oncology team in thepreparation and maintenance of regulatory product strategies for development ofmarketed products submitted to the European Medicines Agency and nationalcompetent authorities in AbbVie’s Western Europe region and regulatory agenciesin Turkey, Switzerland and Israel.
Ensuresinclusion of strategic messaging in the content of WE RA dossiers.
Leadsregulatory team in the preparation and maintenance of risk assessment andmitigation strategy development for the oncology portfolio.
Builds,coaches and manages high performing, qualified teams, implementing the AbbVieRA vision, and truly living the AbbVie ‘Ways we Work’.
Leads theteam by ensuring that company policies and procedures for regulatory recordkeeping are followed, and may contribute to the development and implementationpolicies and procedures within the RA department.
Maintains anactive awareness of EU legislation and its impact on AbbVie business andR&D programmes. Develops and executes strategies to respond to those.
Qualifications & experience:
Extensivepharmaceutical industry experience in European Regulatory Affairs (includingIsrael, Turkey and Switzerland)
PreviousOncology experience is preferred.
Experienceworking effectively across cultures
At easein operating in a matrix environment.
Strongdynamic presence with experience of leading teams.
Travel: Yes, 25 % of the Time
Job Type: Experienced