Regulatory Affairs Consultant
210 East Grand Ave South San Francisco, CA 94080 US
- Lead program teams in preparing regulatory submissions including briefing documents, IND/CTA/BLA filings, and marketing applications
- Oversee preparation of responses to all regulatory authority queries
- Plan and lead meeting 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 CMC team. Serve as primary regulatory representative (for assigned projects) at internal meetings as well as at meetings with regulatory agencies for all clinical related issues
- Maintain detailed knowledge of global regulatory environment relevant for 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, CROs to provide regulatory guidance.
- Escalate issues to Management that affect registration, regulatory compliance and continued lifecycle management of the product
- 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 Orphan Drug Designation, BTD and RMAT is preferred
- Manage contract staff and vendors as needed to support regulatory activities
- 10+ years of experience 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
- Experience in biologics is preferred
- Experience with regulations or product development in gene therapy, such as CAR-Ts, AAVs, or CRISPR technology etc. is highly preferred.
- 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.
- Interpersonal skills that promote a collaborative and productive lab environment
- 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
- Ability to work independently and as part of a team
- Effective and efficient written and oral communication skills
- A minimum of a Bachelor's and or undergraduate degree in biological, pharmaceutical, chemical or engineering sciences is required.
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