Associate Director Regulatory Affairs
The Associate Director, Regulatory Affairs (Clinical Reg Focused) will lead the development and execution of regulatory strategies to support clinical programs across various stages of development. This role partners cross-functionally with clinical, nonclinical, CMC, and program management teams to ensure efficient and compliant regulatory submissions to global health authorities, with a primary focus on the FDA. It is a strategic and hands-on position ideal for a regulatory leader who thrives in a collaborative, fast-paced environment.
This position provides an exciting opportunity for an established Associate Director of Regulatory Affairs or a Strong Senior Manager ready for a step up.
Responsibilities:
- Drive global regulatory strategy and implementation for one or more clinical-stage programs.
- Act as the primary regulatory representative for assigned programs, including direct communication with the FDA and other regulatory authorities.
- Oversee and contribute to the preparation of regulatory documents such as INDs, amendments, briefing books, and orphan drug applications.
- Provide regulatory guidance and oversight to cross-functional teams regarding clinical trial protocols, study reports, and development strategy.
- Monitor and interpret changes in the regulatory landscape and assess potential impact on programs.
- Coordinate and lead regulatory interactions, including meeting preparation and participation.
- Manage external regulatory consultants and vendors, as needed.
Qualifications:
- Bachelor's degree in life sciences; advanced degree (PhD, PharmD, or MS) preferred.
- 8-12 years of regulatory affairs experience within the biotech or pharmaceutical industry.
- Proven expertise in regulatory strategy and submission management for clinical-stage programs, particularly in the U.S.
- Experience interfacing with the FDA and contributing to IND strategy and execution.
- Strong cross-functional leadership skills and ability to work in a dynamic environment.
- Excellent written and verbal communication skills.
If you are interested in finding out more please Easy Apply with your updated resume or email me on or call me on
Notes:
- 2/3 Days hybrid
- Relocation assistance can be provided should you want to relocate to California
- Sponsorship can be considered