San Francisco OR Remote
25 days ago
- Provide strategic guidance to multidisciplinary teams on the regulatory requirements to support all stages of clinical development of biologics and/or small molecules, including timely development and execution of robust global regulatory strategies
- Lead multidisciplinary teams in the authoring of regulatory documents, including scientific advice briefing packages, INDs/CTAs and amendments.
- Works with technical and functional representatives to manage and submit product prioritization designation requests, e.g. orphan drug, rare pediatric designation, breakthrough therapy, fast track, accelerated approval, PRIME, etc., in the US and EU.
- Manages interactions with Regulatory consultants and contract research organizations, as needed.
- Oversee and ensure compliance with regulatory procedures and work practices; support processes by which regulatory submissions are reviewed, finalized, and signed-off
- Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks
- Assure compliance with project team timelines and milestones
- Manage and track queries from and commitments to health authorities, collaborate with subject matter experts to provide written responses to queries, and provide periodic status updates regarding unfulfilled conditions/commitments
- Responsible for maintaining a strong knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams.
Skills and Qualifications:
- Bachelor's degree in a Life Sciences discipline or equivalent, advanced degree preferred
- Minimum of 5-8 years of experience in Regulatory Affairs
- Strong knowledge of FDA/ICH and foreign regulations and guidelines for the development of biologic products and small molecule
- Excellent organizational, interpersonal, and communication skills with the ability to build relationships at all levels of the organization
- Ability to work independently on multiple projects with tight timelines and minimal supervision
- Experience working in cross-functional, global, virtual teams
- Demonstrated regulatory experience in coordinating the preparation of US and international regulatory submissions
- Experience in eCTD format and structure
- Balance of strategic thinking and strong analytical skills with ability to execute
- High attention to detail; ability to organize, prioritize, and delegate assigned projects