Senior Director, Regulatory Affairs

Job Title: Senior Director, Regulatory Affairs - Advanced Therapies

Job Type: Full-time, permanent position

Location: UK, – Remote

Remuneration: £150,000 + Benefits

Cpl Life Sciences is collaborating with a prestigious global drug development consultancy business that specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug development activities. The business has a specific focus on advanced therapies, cell therapy, ATMPS, and other niche and challenging therapeutic areas.

As the Senior Director of Regulatory Affairs, you will provide support to the Regulatory Affairs team across a range of projects. You will work closely with the Vice President of Regulatory Affairs to oversee the team.

Responsibilities for this role include:

·       Lead client projects, providing strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input, incentives and early market access (such activities will include gap analyses, advice on filing routes, timings, regulatory authority interactions, paediatric development, orphan drug designation and PRIME/Breakthrough Therapy or Regenerative Medicines Advanced Therapy Designation [BTD/RMAT] applications).

·       Preparation of regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, clinical trial applications and investigational new drug applications, PIPs/PSPs, PRIME/BTD/RMAT and marketing authorisation applications.

·       Provide leadership to a team of 4 regulatory affairs professionals, supporting development plans, offering training and development to the whole team. 

·       Lead regulatory agency interactions/negotiations to ensure client goals are met.

·       Completes senior QC review as required.

·       Leads on complex, multifactorial regulatory projects requiring input from several functions and takes the necessary actions to highlight and mitigate potential risks to timelines, budget and deliverables for clients.

·       Acts as Subject Matter/Functional Area Expert.

·       Drafting of cost proposals, tracking of budgets vs. actuals and management of projects to time and budget.

·       Resolve internal/external project issues as needed, with escalation to senior management where required.

·       Work with the Quality function to ensure applicability and compliance for regulatory affairs activities.

Requirements for this role:

·       Minimum of a B.Sc. in a life sciences subject and/or a higher degree preferably a PhD but this isn’t essential.

·       At least 12+ years in Regulatory Affairs within a complex therapeutic area.

·       Extensive experience in early stage drug development.

·       Confident with UK, EU, and US health authorities and drug pathways.

·       Experience in dealings with the EMA (scientific advice, orphan designation, PIPs).

·       Experienced in driving global Regulatory Affairs Strategies.

·       Experience of bringing a product through EU approval is a distinct advantage.

·       Ability to negotiate and concisely express clear positions to stakeholders at all levels.

·       Experience of directly working with national regulatory agencies and leading agency meetings face to face.

·       Excellent written and verbal communication skills.

·       Someone who has had previous leadership experience and is confident in management.

·       Happy with supporting all ongoing projects and business activities as required, including mentoring and line management of regulatory staff as appropriate.

·       Support for business development activities as needed (e.g. calls with potential clients, and support for activities such as conferences, exhibitions and seminars).

·       Maintain up-to-date regulatory knowledge and contribute to the company’s regulatory intelligence function.

An excellent opportunity to join a growing organisation at the heart of drug development. This is a role that will offer the right candidate to be challenged in a healthy environment, gain broader exposure and be at the heart of complex science.

For more information please contact lucy.kirkaldy@cpl.com