Job Title: Director of Global Regulatory Affairs
Job Type: Full-time permanent position
Location: Hertfordshire, UK – Hybrid (2/3 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 submission of Neurology clinical trial applications, product registration dossiers, supplements, 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 answers 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 on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices.
· Serves as regulatory representative to project team, developing regulatory strategy for Eisai assets and providing.
· 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 Clinical Trial Applications, including submission and maintenance
· 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