Regulatory Therapeutic Head

This is a brilliant opportunity for a Regulatory Therapeutic Head to join a renowned biopharmaceutical company who have approximately 25000 employees placed in over 170 countries, this particular role will be based in West London. This diverse company who specialise in research and development focus on producing strong clinical performances, assessable patient benefits and economic value.

The core purpose of this role is to support the company's regulatory mission, which is, with a focus on our patients, to design and deliver optimized global regulatory strategies for Western Europe that align with the company'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.

Job Responsibilities:

• Leads 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.
• Builds, coaches and manages high performing, qualified teams, implementing the company's RA vision, and truly living the company's way of working.
• Leads the team by ensuring that company policies and procedures for regulatory record keeping are followed and may contribute to the development and implementation policies and procedures within the RA department.
• Maintains an active awareness of EU legislation and its impact on company business and R&D programmes. Develops and executes strategies to respond to those.

Skills and Requirements:

• Extensive pharmaceutical industry experience in European Regulatory Affairs (including Israel, Turkey and Switzerland).
• Degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject.
• Experience working effectively across cultures. At ease in operating in a matrix environment.
• Strong dynamic presence with experience of leading teams to success.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call David Dixon on +44 203 078 9544 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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