WHAT YOU’LL DO

• Lead program teams in preparing regulatory submissions including briefing documents, INTERACT/IND/CTA/BLA filings, and marketing applications
• Oversee preparation of responses to all regulatory authority queries
• Plan and lead meetings with regulatory authorities, including end-of-phase 1/2 meetings.
• Manage critical clinical regulatory timelines and work with team members to resolve issues related to non-clinical studies, and clinical development and work in partnership with the CMC team. Serve as primary regulatory representative on assigned projects at internal meetings as well as at meetings with regulatory agencies for all clinical and CMC-related issues
• Maintain detailed knowledge of the global regulatory environment relevant to cell therapies and regenerative medicine including accelerated review programs. 
• Communicate changing regulatory agency requirements; support pertinent regulatory intelligence per needs of programs
• Collaborate with external consultants, clinicians, and CROs to provide regulatory guidance.
• Experience with Orphan Drug Designation, BTD, and RMAT is preferred
• Experience with companion diagnostics and real-world evidence studies is preferred
• Manage contract staff and vendors as needed to support regulatory activities

WHO YOU ARE

• A minimum of a Bachelor’s and or undergraduate degree in biological, pharmaceutical, chemical or engineering sciences is required.
• 15+ years of experience, at least 10+ years in regulatory affairs, inclusive of postgraduate education and/or Advanced scientific degree preferred in the sciences, or health-related field
• Knowledge of EU and FDA regulations is required. Experience in filing regulatory submissions from early development to pre and post-approval submissions and product lifecycle management in the area of Cell Therapy
• Strong knowledge of eCTD elements and structure and regulatory writing skills
• Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
• Experience with regulations or product development in gene therapy, such as CAR-Ts, AAVs, or CRISPR technology etc. is highly preferred
• Demonstrated enterprise leadership skills and ability to build an experienced regulatory affairs team
• Ability to work in a fast-paced, start-up environment
• Experience directly writing submission documents that support clinical trials, marketing applications, and lifecycle management is highly preferred
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
• Effective and efficient written and oral communication skills
• Candidates must be authorized to work in the U.S
• Ability to work independently and as part of a team