Director / Associate Director: Global Regulatory Consulting - Europe

Salary: £Excellent Salary and Benefits Package

(Job Ref: WR/JOBS/35462)

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Vacancy Details

Flame Pharma are currently working alongside an expert Global Contract Research Organisation to recruit a Director or Associate Director of Regulatory Affairs to join their growing expert team. This innovative company has over twenty five year’s experience across the globe and are world leaders in a range of therapeutic areas.

The Role

This position will join a team of regulatory experts in global product development with therapeutic area expertise and strategic regulatory intelligence.

The Director/Associate Director will be responsible for providing to stakeholders and advising clients on strategic regulatory considerations for non clinical and clinical(I - IV) product development, study designs; product competitive benchmarking, such as review of relevant regulatory precedents for evolving standards; product label key messaging and rigorous regulatory review for successful registration.

The Person

This role requires a suitable level of experience within a broad range of Regulatory Affairs projects with sound knowledge of Global Regulatory Procedures (Drugs/Biologics). Previous team management experience would be an advantage. Good interpersonal skills along with excellent planning and organizational skills are essential.

Candidates will be expected to possess advanced and terminal degrees (PhD, PharmD, MD, MS).

 

 

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