Global Associate Director, Regulatory Affairs

Job Title: Global Associate Director, 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 and Oncology 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.
• Regulatory Submissions (CTA/MAA): Participating in regulatory submission activities and reviewing regulatory documents prior to submission to ensure overall quality, compliance and timeliness. Partnering with project teams to assess regulatory support needs and align resources (i.e., sub teams) to provide regulatory support. Creation of regulatory documents, working with the cross functional team to create responses per Agency timelines.
• Interfacing with Authorities: Acting as the point of contact with regulatory authorities for assigned product(s). Leading calls or meetings with regulatory authorities. Authoring Scientific Advice requests, leading team strategy.
• Regulatory Strategy Development: Contributing to the development of global regulatory strategies across programs for own functional area and region. Identifying, monitoring and resolving regulatory issues and reporting progress to management
• 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.
• 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
• 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