At a Glance
- Tasks: Lead regulatory strategy for innovative oncology and neurology products.
- Company: Established pharmaceutical company focused on cutting-edge science.
- Benefits: Competitive salary, bonus, car allowance, life assurance, and private healthcare.
- Other info: Hybrid work model with opportunities for career growth.
- Why this job: Make a real impact in global health by expediting drug approvals.
- Qualifications: Bachelor's degree and extensive experience in Regulatory Affairs.
The predicted salary is between 70000 - 90000 £ per year.
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.
- 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.
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.
Associate Director, Global Regulatory Affairs employer: Cpl Life Sciences
Cpl Life Sciences is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration within the vibrant streaming and entertainment sector. Employees benefit from immediate project impact opportunities, comprehensive training, and career growth in a cloud-oriented environment, making it an ideal place for those looking to advance their skills in data engineering while working with cutting-edge technologies.
