Manager, Regulatory Affairs

We are recruiting on behalf of a global clinical stage biotech who are looking to hire an Manager 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 Overview

In this role, you will support the advancement of our clinical-stage programs by applying regulatory expertise and ensuring the high-quality execution of regulatory activities. You will work closely with cross-functional teams to coordinate regulatory submissions, support interactions with Health Authorities, and help drive the operational delivery of regulatory plans.

Reporting to the Senior Director of Regulatory Affairs, you will collaborate across clinical, nonclinical, and CMC functions to ensure regulatory deliverables are well-organized, accurate, and aligned with development timelines.

This role offers an excellent opportunity for a hands-on regulatory professional who is looking to take on increasing ownership and expand their experience in a dynamic, fast-paced environment.

Key Responsibilities

• Support Regulatory Affairs leads for assigned programs by contributing regulatory input, identifying operational risks, and assisting with the execution of regulatory plans.
• Contribute to the development and implementation of regulatory strategies aligned with program objectives and global regulatory requirements.
• Conduct regulatory research and provide insights on potential regulatory pathways or scenarios to support team decision-making.
• Coordinate and track regulatory activities across clinical, nonclinical, and CMC teams to enable timely program progression.
• Prepare, compile, and maintain regulatory submissions, including INDs/CTAs, amendments, periodic reports, expedited program requests, and responses to Health Authority inquiries.
• Contribute to the review of key development documents (e.g., clinical protocols, statistical analysis plans, and study reports) to ensure alignment with regulatory expectations and submission readiness.
• Support the planning and execution of Health Authority interactions by helping prepare briefing documents, coordinating content, and organizing meeting materials.
• Collaborate with internal teams and external partners to ensure regulatory deliverables are complete, high-quality, and consistent across documentation.
• Contribute to the continuous improvement of Regulatory Affairs processes, tools, and documentation practices to strengthen compliance and operational efficiency.

Qualifications

• Bachelor’s degree required; advanced degree in life sciences preferred.
• 4+ years of relevant regulatory affairs experience in the biopharmaceutical industry.
• Solid understanding of ICH guidelines and US/EU regulatory requirements, with exposure to global regulatory submissions.
• Experience preparing or contributing to IND/CTA submissions and related regulatory documentation; exposure to NDA/MAA submissions is a plus.
• Strong organizational skills with the ability to manage multiple priorities, track timelines, and anticipate challenges in a fast-paced environment.
• Early phase clinical trial experience.