AX 7163 – Head of Regulatory Affairs Europe Oncology
Opportunity to Lead the Western European Oncology Regulatory Affairs function for our Client, a blue-chip pharmaceutical organisation. The role will see you sit on the EU Regulatory Leadership Team and manage a small regulatory team sitting in the UK. This is a true leadership role, within a strong valued organisation,
Western Europe Regulatory Affairs – Oncology Lead
Sits on Regulatory Leadership Team
Team of eight direct reports
Exciting time to join this portfolio pharma
Office based in the M4 M40 Corridor / 10% to 20% travel
The core purpose of the Head of Regulatory Affairs Oncology role is to support the Our Client’s regulatory mission, which is, with a focus on their patients, to design and deliver optimized global regulatory strategies for Western Europe that align with the 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.
Lead the assigned Western Europe Regulatory Affairs (WE RA) Oncology team in the preparation and maintenance of regulatory product strategies for development of marketed products submitted to the European Medicines Agency and national competent authorities in the company’s Western Europe region and regulatory agencies in Turkey, Switzerland and Israel.
Ensures inclusion of strategic messaging in the content of WE RA dossiers.
Leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for the oncology portfolio.
Exceptional line management skills and experience will be required to harmonize the existing team and ensure endurance to our Client’s strong values and cultural identity. Recruitment, development, retention and visible leadership will be key in this position.
Stock, Bonus, Car, Pension, Life Assurance
QUALIFICATIONS / EXPERIENCE REQUIRED:
Degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject.
Extensive pharmaceutical industry experience in European Lifecycle Regulatory Affairs.
Experience working effectively across cultures. At ease in operating in a matrix environment.
Strong dynamic presence with experience of leading teams to success.
Proven experience liaising with senior stakeholders.
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300. To apply, please click the Apply Now button quoting reference AX 7163
Head of Regulatory Affairs / Regulatory Affairs Oncology Lead / European Head of Regulatory Affairs / VP Regulatory Affairs Europe / Head of Reg Affairs / Senior Regulatory Affairs Director / Oncology / UK / Berks / BUCKS / Pharma Reg Affairs Leader / Oncology Regulatory Leader / MAAs / Clinical Development / Strategic Leadership / Life Sciences
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