Senior Regulatory Affairs Leader - Biotech Ingredients

Breakout Ventures; Alameda (CA); On-site; USD 160,000 - 200,000; Full time

Job summary

Checkerspot Biosciences is seeking a hands-on Sr. Manager or Director of Regulatory Affairs to establish the regulatory basis for its ingredient technologies and secure approvals in the United States and priority international markets.

You will lead FDA engagements, coordinate QA/QC with manufacturing partners, and guide external consultants while building a comprehensive regulatory strategy. The role requires deep experience in GRAS, NDIN, and European/EU duties, with a track record leading

Qualifications

• Bachelor’s degree in food science or related field.
• 10+ years in regulatory roles for food ingredients or biotechnology, with leadership in strategy.
• Hands-on GRAS submissions and FDA interaction experience.
• Knowledge of U.S. GRAS, NDIN, food additive processes and NDIN.
• Experience coordinating with QA/QC and manufacturing partners.
• Ability to lead cross-functional teams and manage budgets.

Responsibilities

• Develop regulatory strategies for ingredient technologies based on FDA GRAS, NDIN, and international pathways.
• Lead regulatory execution with clear milestones, timelines, and resources.
• Serve as FDA primary contact and manage GRAS submissions and responses.
• Direct dossiers covering identity, manufacturing, and safety justifications.
• Manage external regulatory consultants and maintain internal ownership of strategy.
• Work with scientists to close evidence gaps through analyses and assessments.
• Prioritize EU novel food work and market access in priority regions.
• Oversee QA/QC with partners and ensure compliance and product release.

Skills

Regulatory leadership

Cross-functional collaboration

Strategic planning

Project management

FDA communications

Team management

Education

Master's or PhD in a relevant discipline

Job description

Checkerspot Biosciences is seeking a hands-on Sr. Manager or Director of Regulatory Affairs to establish the regulatory basis for its ingredient technologies and secure approvals in the United States and priority international markets.

You will lead FDA engagements, coordinate QA/QC with manufacturing partners, and guide external consultants while building a comprehensive regulatory strategy. The role requires deep experience in GRAS, NDIN, and European/EU duties, with a track record leading