Associate Director, Global Regulatory Affairs Strategy

Job Title: Associate Director, Global Regulatory Affairs

Job Type: Full-time permanent position

Location: Hertfordshire, UK – Hybrid (3 days per week in the office)

Remuneration: Competitive benefits package

An exciting opportunity to join an established pharmaceutical company that specialises in Oncology and Neurology. The role will be working across both portfolios and will have a heavy focus on regulatory strategy.

Directing the development of submissions of Oncology or Neurology clinical trial applications, product registration dossiers, supplements, and amendments. Provides strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions.

A great opportunity to demonstrate your knowledge in leading regulatory processes for products across the globe, with a focus on oncology and neurology. In this unique position, you will interact with a wide and diverse range of colleagues across the organisation.

Responsibilities: 

• Provides strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions.
• Interact and negotiate with regulatory agency personnel in order to expedite approval of pending registration and answer any questions.
• Serves as a regulatory liaison on the project team throughout the product lifecycle.
• Ensures that clinical trial designs meet regulatory requirements. Ensures rapid and timely approval of new drugs, biologics/biotechnology, and/or medical devices and continued approved status of marketed drugs.
• Serves as regulatory representative to the project team, developing regulatory strategy for assets.
• Advice on all aspects of product development from a regulatory perspective.

Requirements:

• Bachelor's degree
• Extensive industry experience with demonstrated experience in direct Regulatory Affairs in the biotech/biopharmaceutical industry.
• Demonstrated track record of interfacing effectively with global regulatory agencies, such as the EMA.
• Experience in Clinical Trial Applications, including submission and maintenance
• PIPS (Paediatric Investigation Plan) experience preferred but not required.
• Strong understanding and practical experience with regulations and guidelines governing pharmaceutical development and registration.

An excellent opportunity to work for a leading pharmaceutical company at the heart of science and neuroscience development. The role comes with some excellent benefits, including a bonus, car allowance, life assurance, pension scheme, and private healthcare.

This role does not provide sponsorship, and you must have the Right to Work in the UK.

For more details about this position, please feel free to contact lucy.kirkaldy@cpl.com