Job Description
Job Description
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 Director of Regulatory Affairs is responsible for developing, implementing and leading short- and long-term global regulatory strategies that support the success of products throughout their lifecycle.
Serves as the primary liaison to regulatory agencies and leads submission activities to regulatory agencies. Identifies and assesses regulations and guidance documents and provides interpretive guidance and applicable implementation.
This position will work within cross-company development project teams and will provide regulatory expertise into strategic regulatory plans.
Key Responsibilities
- Leads and defines the global regulatory strategy and executes regulatory strategies
- Preparation and / or supervision of preparation of regulatory submissions including, INDs, CTAs, GMOs, IDEs, amendments, annual reports, meeting briefing documents, responses to regulatory agency information requests, marketing authorization applications, and other regulatory submissions, as applicable.
- Serves as the primary liaison with FDA and other regulatory agencies throughout development of projects, including regulatory agency meetings and teleconferences
- Identify and assess existing and new regulations, guidance documents, international standards, or consensus standards; and provide interpretive guidance and ensure applicable implementation into development planning and execution
- Ensures that all regulatory activities and documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance to facilitate agency review and acceptance
- Represents Global Regulatory Affairs as the primary contact on regulatory aspects of the projects and as a member of the cross-functional project team, providing regulatory guidance / strategy / perspective in team meetings and presentations at senior leadership governance meetings
- Oversees regulatory staff and participate in skill-development, coaching, and performance feedback of regulatory staff
- Manages vendors and / or clinical research organizations (CROs) performing regulatory activities on behalf of the company
- Participate in due diligence activities on potential licensing, acquisition, or collaboration opportunities
- Reviews and establishes standard operating procedures (SOPs) and global regulatory affairs processes
Qualifications & Experience
Required
- Bachelor’s Degree
- At least 10 years of Global Regulatory Affairs experience
- Must have experience filing regulatory dossiers (CTAs, INDs, IMPDs)
- Track record of leading regulatory activities for development program
- Experience leading regulatory interactions including formal meetings
- Solid working knowledge of relevant domestic and global regulations and guidance
- Experience working a matrix team environment
Desirable
- Advanced degree (e.g., PhD, PharmD)
- Experience in cell and gene therapy and / or oncology is strongly preferred
- Experience with BLAs / NDAs / MAAs preferred
- Companion diagnostic experience (IDE, PMA / 510K) desirable
- Experience managing staff
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.
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