Associate Director, Global Regulatory Affairs CMC
Adaptimmune is a fully integrated commercial-stage cell therapy company, designed and built from the ground up with UK- and U.S.-based biotechnology hub locations. In the U.S., locations are in Cambridge, MA and Philadelphia, PA. In the UK, locations are in Oxford and Stevenage. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
primary Responsibility
The Associate Director of Global Regulatory Affairs CMC is responsible for the development and execution of global Chemistry, Manufacturing, and Control (CMC) regulatory strategies that support the success of products throughout their lifecycle. This role is accountable for the development and filing strategies for CMC modules/updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications, and other regulatory documentation (GMO, briefing documents, responses to IRs, etc.) for assigned products. This role provides regulatory guidance to various cross-functional teams on CMC regulatory strategy to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development strategy of the assigned products. This role will be a key interface between CMC subject matter experts (SMEs) and Global Regulatory Affairs.
Key Responsibilities
- Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products
- Acts as point of contact to cross-functional teams on regulatory CMC project issues. Ensures project teams, line management, and key stakeholders are apprised of developments that may impact regulatory success and timelines, exercising sound judgement, and communicating in a professional and timely manner.
- Effectively communicate regulatory CMC strategy, risks, mitigations, and overall plans to project team, regulatory leadership team, and key stakeholders, as relevant.
- Actively collaborates with internal and external teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners, and CROs) to develop and execute robust CMC regulatory strategies
- Plans, executes, and manages regulatory CMC submissions including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, responses to CMC Information Requests, etc.
- Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments)
- Perform life cycle management for marketed products on a global basis, including regulatory impact assessments and preparation of CMC documentation for variations and other post marketing submissions
- Ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends, and to drive and implement strategic policy decisions
- Evaluates change proposals for global regulatory impact and plans global amendments
- Assess change controls and provide assessment of regulatory impact
Qualifications & Experience
Required
- Bachelor’s Degree in a scientific discipline is required; advanced degree is preferred.
- Minimum of 8 years of relevant pharmaceutical/biotech experience including 5 years of Regulatory Affairs CMC experience
- Experience with pharmaceutical development of drug substance and drug products, including analytical characterization and manufacturing process development
- Proven understanding and ability to provide regulatory strategic guidance to drug development, registration, and post-market support teams.
- Successful track record of providing robust regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
- Experience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs)
- Ability to effectively liaise with Regulatory Agencies, having served as lead in successful Agency interactions related to CMC submissions and product development meetings; international experience preferred
- Knowledge of relevant domestic and global regulations and guidance
- Ability to work effectively in cross-functional teams
- Experience as a RA CMC product lead is strongly preferred
- Experience in cell and gene therapy is strongly preferred
- Experience with BLAs/NDAs/MAAs is preferred
other requirements
- Travel as required for internal and external meetings, including health authority meetings.
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.