Regulatory Consultant in Newcastle upon Tyne

Regulatory Affairs CMC Consultant 9-month maternity leave coverage. Remote, UK.

Our client is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. The company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognise cancer cells, break down their defence mechanisms and eliminate these cells.

An exciting opportunity has arisen for an experienced Director, Regulatory Affairs CMC to join the team to take a leadership role for developing global CMC regulatory strategies and content plans for products across our cell and gene therapy portfolio.

We are looking for a Director, Regulatory Affairs CMC with proven expertise leading CMC product development strategies as well as clinical trial, IND, BLA and MAA filing experience. The successful candidate will be involved with working on innovative and pioneering Advanced Therapy Investigational Medicinal Products (ATIMPs) to treat cancers and benefit from working with cutting edge technologies and being a key influencer to shape CMC regulatory requirements for such therapies globally.

As a key member of the Regulatory Affairs CMC team, the candidate will have responsibility for developing CMC regulatory strategy for the clinical portfolio from a Regulatory CMC perspective and for communicating critical issues to Senior Management. The candidate will ensure that the CMC development strategy meets global regulatory requirements over the lifecycle of the product and is in alignment with global regulatory strategy, portfolio strategy, commercial strategy, and the Target Product Profile (TPP).

The Director, Regulatory Affairs CMC will be responsible for establishing regulatory policy for the company and represent the company at external meetings and at Industry Associations.

• To develop and execute global CMC regulatory strategy for assigned products; ensuring CMC strategy is in alignment with the global regulatory strategy, portfolio strategy, commercial strategy, and the Target Product Profile (TPP);
• To act as the CMC Regulatory Lead on CMC Teams, representing the CMC Regulatory viewpoint and expertise on the CMC Team;
• To identify potential CMC regulatory risks to the strategic / operational plans and propose options to mitigate risks;
• To plan, prepare, review CMC components of briefing packages in connection with health authority scientific advice and (pre-)submission meetings;
• To provide CMC Regulatory support to pre-approval and GMP inspections;
• To lead meetings with Health Authorities in connection with CMC regulatory questions and engage in appropriate interactions to increase the predictability of regulatory outcome;
• To provide input to plans associated with manufacturing site(s), commercial packaging selection and supply chain where decisions may have an impact on the filing strategy;
• Ensure compliance with Health Authority CMC related Regulations and ensure awareness of cell and gene therapy guidelines;
• Liaise with cross-functional CMC and manufacturing team members and external providers to ensure timely and effective regulatory submissions in support of product progression;
• Oversees and directs all regulatory activities for new clinical products to ensure alignment and compliance with local and regional registration requirements as well as with company policies;
• To be responsible for development and training of CMC staff in regulatory matters and to communicate the impact of new regulatory requirements across the Company.

At least 10 years’ experience in Regulatory Affairs with a core expertise in CMC (E); Strong experience with interfacing with the health authorities globally and an excellent track record of building relationships with regulators and influencing regulatory outcomes (E); Ability to provide technical input, proven ability to plan, coordinate and author regulatory documents simultaneously on multiple projects (E); Bachelor’s degree in Life Science (E) and Master or PhD (P).