(Associate) Director, Regulatory Affairs CMC

Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.

Role Summary

An exciting opportunity has arisen for an experienced Associate Director/Director, Regulatory Affairs CMC 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 an Associate Director/Director, Regulatory Affairs CMC with proven expertise supporting/leading CMC post-approval strategies as well as 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 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 supporting/developing CMC post-approval regulatory strategy for the Autolus commercial 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, Autolus portfolio strategy, commercial strategy, and the Target Product Profile (TPP). The Associate Director/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 support/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 and be accountable for 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;
• Responsible for global regulatory evaluation of CMC change controls;
• Facilitate CMC submission document review meetings and discussions;
• To support/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;
• Support/Lead departmental and cross-functional initiatives to drive efficiencies and increased collaboration;
• 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
• At least 8/10 years’ experience in Regulatory Affairs with a core expertise in CMC for biologics (E);
• Excellent working knowledge of EU CMC regulations and guidelines related to cell and gene therapies (P);
• Significant experience in CMC biologic post-approval submissions and regulatory strategy for EU and UK 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);
• Strong regulatory authoring expertise and willingness to support authoring of key regulatory documents (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).

Autolus Core Competencies

• Focus on Results: Works to meet business goals set by management and leaders
• Builds Trust and Relationships: Ensures trust with internal and external partners by delivering on commitments
• Resilience: Has the capacity to recover quickly from difficulties; toughness
• Communicates and Collaborates: Builds partnerships and works collaboratively with others to meet objectives

Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.