Regulatory CMC Consultant

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

About our Client: Our client is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies. The company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognise cancer cells, break down their defense mechanisms and eliminate these cells.

Role Summary: 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.

What are we looking for: 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. Large molecule biologics CMC experience is essential with experience in cell and/or gene therapy highly desired. 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.

Key Responsibilities

• 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 related submission documentation and to provide input to and be accountable for the preparation of CMC dossiers for submission to Health Authorities (BLA / MAA / IND / CTA etc.);
• 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;
• Lead departmental and cross-functional initiatives to drive efficiencies and increased collaboration;
• 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.

Demonstrated skills and competencies E – Essential P – Preferred Experience

• At least 10 years’ experience in Regulatory Affairs with a core expertise in CMC (E);
• Excellent working knowledge of FDA and EU CMC regulations and guidelines related to cell and gene therapies (P);
• Significant experience in CMC biologic drug development and US INDs/BLAs, EU CTAs/MAAs (E). Submissions with cell and or gene therapies (P);
• 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);
• Ideally a combined mix of large company best practices and smaller company adaptability and experience (P);
• Excellent communication skills with excellent presentation skills and the ability to work collaboratively (E);
• Proven strong organisational and strategic skills (E);
• Proven negotiating and influencing skills (E);
• A track-record of ability to handle critical issue situations effectively (E).

Qualifications

• Bachelor’s degree in Life Science (E) and Master or PhD (P).