Position Overview
We are seeking an experienced Director of Regulatory Affairs to develop and execute global regulatory strategies across clinical, non-clinical, and CMC areas. This role will be responsible for ensuring the timely submission of well-organized, scientifically sound regulatory documents. The ideal candidate will provide strategic guidance to project teams, including international stakeholders, and translate regulatory requirements into actionable plans. This position may involve mentoring and managing other regulatory professionals and requires the ability to work both independently and collaboratively in a fast-paced environment. The role is based in Palo Alto, CA.

Key Responsibilities

• Lead the development and execution of regulatory strategies across clinical, non-clinical, and CMC areas in partnership with cross-functional teams.
• Provide expert guidance on regulatory requirements and timelines to support product development and lifecycle management.
• Contribute to global clinical regulatory plans, identify potential risks, and recommend mitigation strategies.
• Act as the company’s primary point of contact with regulatory agencies, representing the organization in all regulatory interactions.
• Prepare and manage complex regulatory submissions, collaborating with internal teams to ensure accuracy and alignment with strategic goals.
• Maintain in-depth knowledge of current global and regional regulatory requirements, communicating changes and updates to project teams.
• Develop internal regulatory policies and best practices to enhance efficiency and compliance.
• Oversee and guide direct reports, managing work assignments and ensuring timely project delivery.
• Provide strategic and operational input to cross-functional teams, ensuring consistency and alignment across regulatory disciplines.
• Review technical documents critically and provide expert feedback to improve submission quality.
• Support the preparation and filing of regulatory dossiers, including CTAs, INDs, and IMPDs, with additional involvement in marketing applications as needed.
• Contribute to regulatory strategies for drug-device combination products and related filings.
• Travel domestically and internationally up to 10–20% of the time.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Minimum 10 years of regulatory affairs experience, including management of investigational and marketed products.
• Experience working on cross-functional and international teams is highly desirable.
• Strong knowledge of global and regional regulatory requirements, including ICH guidelines and emerging trends.
• Proven ability to lead the preparation and submission of complex regulatory documents.
• Experience with drug-device combination products is a plus.
• Direct experience with regulatory filings, including CTAs, IMPDs, and INDs, is required; experience with marketing applications is a plus.
• Strong communication and leadership skills, with the ability to influence and guide cross-functional teams.
• Ability to manage multiple projects under tight deadlines with excellent organizational skills.