Job Description

We are recruiting on behalf of a global clinical stage biotech who are looking to hire a Senior 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

You will play an important role in advancing our clinical-stage programs by providing regulatory expertise and supporting the execution of global regulatory activities. As a member of the development team, you will collaborate closely with cross-functional partners to coordinate regulatory deliverables and ensure alignment across program activities.

Reporting to the Senior Director of Regulatory Affairs, you will contribute to the preparation of regulatory submissions, support interactions with Health Authorities, and help drive the effective implementation of regulatory plans.

Key Responsibilities

• Represent Regulatory Affairs for assigned programs by providing regulatory guidance, identifying potential risks, and supporting 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 to evaluate potential regulatory pathways, identify risks, and inform strategy.
• Plan and coordinate regulatory activities across clinical, nonclinical, and CMC teams to support timely program advancement.
• Prepare and maintain regulatory submissions, including INDs/CTAs, periodic reports, expedited program requests, and responses to Health Authority inquiries.
• Provide regulatory review and input for key development documents, including clinical protocols, statistical analysis plans, and clinical and nonclinical study reports, ensuring alignment with regulatory expectations.
• Support the planning and execution of Health Authority interactions by contributing to meeting strategy, drafting briefing materials, and coordinating responses.
• Collaborate with cross-functional teams and external partners to ensure regulatory deliverables are accurate, high quality, and delivered on schedule.
• Contribute to the development and continuous improvement of Regulatory Affairs processes to strengthen compliance and operational efficiency.

Qualifications

• Bachelor’s degree required; advanced degree in life sciences preferred.
• 5+ years of relevant regulatory affairs experience in the biopharmaceutical industry.
• Strong understanding of ICH guidelines and US/EU regulatory requirements, with experience supporting global regulatory submissions.
• Hands-on experience preparing and managing IND/CTA submissions required; NDA/MAA experience is a plus.
• Ability to manage multiple priorities in a fast-paced environment while identifying challenges and collaborating across teams to develop solutions.
• Strong organizational and communication skills, with the ability to clearly communicate regulatory concepts to cross-functional stakeholders.
• Comfortable working in a dynamic, small-company environment with broad responsibilities and evolving priorities.

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