(Senior) Director Regulatory Affairs CMC
2 weeks ago
Location: United Kingdom
Job SummaryRole Summary
An exciting opportunity has arisen for an experienced CMC Regulatory Affairs Sr. Director to join the Autolus team to take a leadership role for developing global CMC regulatory strategies and content plans for products across Autolus’ cell and gene therapy portfolio. Autolus is looking for a CMC Regulatory Affairs Sr. Director 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 senior regulatory team the candidate will have responsibility for developing CMC regulatory strategy and 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, Autolus portfolio strategy, commercial strategy, and the Target Product Profile (TPP). The person will be responsible for executing the regulatory policy and represent the CMC regulatory at internal and external meetings. The candidate may be responsible for managing staff including; objective setting and career development activities.
Key Responsibilities
• To develop and execute global CMC regulatory strategy for assigned products; ensuring CMC strategy is in alignment with the global regulatory strategy, Autolus 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;
• 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
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