What are the responsibilities and job description for the Director, Regulatory CMC position at SciPro?
SciPro is partnered with an exciting late-stage biotech that is seeking a Director, Regulatory CMC to join their team full-time. This role will lead the development and execution of global regulatory strategies and play a key role in guiding regulatory submissions, ensuring compliance throughout the product lifecycle, from development to commercialization.
We’re looking for a Regulatory CMC expert and strategic leader who thrives on solving complex challenges and navigating ambiguity. The ideal candidate is a hands-on project manager who excels in fast-paced, evolving environments and takes pride in delivering high-quality work.
This is a hybrid position with 3 days onsite near Somerset, NJ.
Responsibilities
- Lead and implement CMC regulatory strategies across pipeline and marketed programs.
- Prepare, review, and submit high-quality regulatory documentation (e.g., INDs, NDAs, amendments, supplements) aligned with global health authority requirements.
- Serve as a primary point of contact for CMC-related regulatory interactions with agencies such as FDA and EMA.
- Provide strategic input to cross-functional teams to ensure development plans align with regulatory expectations.
- Mentor a team of regulatory professionals, fostering collaboration and accountability.
- Monitor evolving regulatory guidelines and assess their impact on programs and documentation.
- Support inspection readiness efforts and participate in health authority inspections as needed.
- Contribute to the development of internal CMC regulatory processes and best practices.
Qualifications
- Advanced degree (PhD, PharmD, MS) with 10 years, or Bachelor's degree with 12 years, of relevant experience in Regulatory Affairs, with a strong focus on CMC.
- Proven experience with supporting viral vector product development,
- Demonstrated success in authoring and compiling regulatory dossiers for global filings.