Associate Director Regulatory Affairs

We are recruiting on behalf of a global clinical stage biotech who are looking to hire an Associate Director Regulatory Affairs to join their team on a permanent basis. Working onsite in San Francisco 3 days per week, the ideal candidate will bring small molecule experience and a proven biotech background.

Role Specification

You will play a key role in advancing clinical-stage programs by providing regulatory expertise and driving the execution of regulatory activities. As a core member of the development team, you will work closely with cross-functional partners to support and manage global regulatory initiatives. Reporting to the Senior Director of Regulatory Affairs, you will lead the preparation of regulatory submissions, support interactions with Health Authorities, and help ensure the effective implementation of regulatory strategies.

Key Responsibilities

• Serve as the Regulatory Affairs lead for assigned programs, providing strategic guidance, identifying regulatory risks, and developing mitigation plans to support program advancement.
• Contribute to the development and implementation of regulatory strategies aligned with corporate goals and global regulatory requirements.
• Conduct regulatory intelligence and research to evaluate potential regulatory pathways, inform strategy, and proactively identify risks.
• Coordinate and manage regulatory activities across clinical, non-clinical, and CMC teams to ensure timely progression of development programs.
• Lead the preparation, submission, and maintenance of regulatory documentation, including INDs/CTAs, periodic reports, expedited program requests, and responses to Health Authorities.
• Provide regulatory input to key development documents such as clinical protocols, statistical analysis plans, and clinical/nonclinical study reports to ensure compliance with regulatory expectations.
• Support Health Authority interactions by contributing to meeting strategies, drafting briefing materials, and coordinating responses to regulatory questions.
• Collaborate with internal teams and external partners to deliver high-quality regulatory submissions aligned with development timelines.
• Promote continuous improvement of Regulatory Affairs processes to strengthen compliance and operational effectiveness.

Qualifications

• Bachelor’s degree required; advanced degree in life sciences preferred.
• 7+ years of relevant regulatory affairs experience within the biopharmaceutical industry.
• Strong knowledge of ICH guidelines and US/EU regulatory frameworks, with proven experience supporting global regulatory submissions.
• Demonstrated experience preparing and managing IND/CTA submissions required; experience with NDA/MAA submissions is a plus.
• Proven ability to manage multiple priorities in a fast-paced environment while identifying challenges and developing cross-functional solutions.
• Excellent organizational and communication skills, with the ability to translate complex regulatory requirements for diverse teams.
• Experience within early phase clinical trials.
• Must be versatile and able to work cross-functionally.

To arrange an informal discussion, please apply now with an updated CV.

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