Job Description

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 [email protected] or call me on 919-647-9154

Notes :

• 2/3 Days hybrid
• Relocation assistance can be provided should you want to relocate to California
• Sponsorship can be considered

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