Senior Director Regulatory Affairs
3 months ago
Job title: Senior Director Global Regulatory Affairs
An Innovative global pharmaceutical business is seeking a Senior Director Global Regulatory affairs to join their team. In this role you will provide strategic leadership and oversight to the Regulatory Affairs organisation, and responsible for developing and directing regulatory strategy, objectives, policies, and programs from early-stage development through marketing approval and life cycle management.
Responsibilities:
- Lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialisation of the company’s pipeline products.
- Build and nurture relationships with Health Authorities for successful interactions, such as scientific advice meetings, and outcomes.
- Strategic Regulatory leadership for the portfolio of products with overall responsibility for developing, owning and executing the global regulatory affairs plan for each asset.
- Keep abreast of global regulatory requirements assessing risks and developing contingency plans.
Requirements:
- Extensive regulatory experience working on Innovative medicines.
- A broad and demonstrated understanding of drug development and commercialization processes with a robust knowledge of GxP considerations.
- Experience operating at a senior strategic and decision making level.
- Proven line management experience.
Salary and benefits:
A highly competitive salary and wider benefits scheme is on offer.
To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk
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