The Regulatory Science Director will serve as a key member of the Regulatory Science team within a clinical-stage biotechnology company. This role will be responsible for developing and executing global regulatory strategies and ensuring timely preparation and submission activities to support clinical trials and regulatory interactions worldwide.
This is a technical, individual contributor role with cross-functional impact, working closely with development teams and external partners. The successful candidate will guide regulatory decision-making across development stages and contribute to both Clinical and CMC regulatory activities for a growing oncology pipeline.
Key Responsibilities
- Oversee Clinical Trial Submissions: Coordinate and oversee the preparation of clinical trial applications across multiple regions, including the United States and Asia-Pacific. Ensure that all submissions are timely, complete, and meet relevant regulatory requirements. Support the preparation and submission of applications for regulatory designations (e.g., Fast Track, Breakthrough Therapy, Orphan Drug, etc.).
- Hands-On Implementation: Actively engage in the drafting, review, and coordination of regulatory documents, ensuring accuracy and timeliness. This role requires both strategic oversight and direct involvement in execution.
- Lifecycle Maintenance of Submissions: Manage post-submission activities including regulatory amendments, protocol and investigator brochure updates, and general IND/CTA maintenance across regions.
- Vendor Oversight: Manage regulatory vendors (e.g., CROs, publishers, consultants), ensuring deliverables are of high quality, aligned with internal expectations, and completed within agreed timelines.
- Adaptability and Problem-Solving: Operate effectively within a dynamic and fast-paced environment where roles and priorities may evolve. Be prepared to address emerging challenges and adjust plans as necessary.
- Cross-Functional Collaboration: Work closely with internal teams, including Clinical Operations, Medical, Safety, CMC, and Nonclinical functions, to align regulatory activities with program goals and timelines. Ensure consistent communication across functions to support submission readiness.
Essential Qualifications
- Educational Background: Bachelor's degree in a relevant scientific or regulatory field is required; a Master's degree is preferred.
- Experience: Minimum of 7 years of experience in regulatory science, clinical trial submissions, or related roles, with demonstrated progression in responsibility.
- Communication: Strong written communication and presentation skills, including the ability to independently prepare clear, well-structured regulatory presentations for cross-functional discussions.
- Regional Experience: Experience with regulatory submissions in the United States and Asia-Pacific region is highly desirable. Experience supporting oncology programs is strongly preferred. Prior experience with NMPA submissions is an advantage.
- Flexible and Adaptive Mindset: Ability to thrive in an environment where processes are evolving and adapt effectively to shifting priorities.
- Hands-On Approach: Willingness to engage directly with operational tasks and ensure strategic plans are executed effectively.