Associate Director/Director, CMC Regulatory Affairs

1w1 week ago

Codexis Inc

Redwood City, US · Full-time · $185,000 – $250,000

About this role

We are seeking an experienced and strategic Associate Director/Director of CMC Regulatory Affairs to lead and execute regulatory activities for our ECO Synthesis platform and associated manufacturing activities. This role advances engagement with the FDA Emerging Technologies Program and supports pursuit of an FDA Advanced Manufacturing Technology Designation. It prepares for GMP manufacturing and regulatory submissions including DMFs and IND support.

Day-to-day involves developing CMC regulatory strategies for the ECO Synthesis platform and GMP siRNA manufacturing. Lead interactions with regulatory agencies like the FDA Emerging Technologies Team. Prepare and manage CMC sections of INDs, DMFs, and amendments while supporting therapeutic developer customers with Module 3 documentation.

Collaborate cross-functionally with Process Development, Quality, Manufacturing, and Business Development teams to ensure regulatory compliance and readiness. Provide regulatory guidance during design and construction of the GMP manufacturing facility. Align documentation with ISO 9001 and future GMP standards.

Ensure compliance with evolving FDA and global expectations for advanced manufacturing technologies. Maintain awareness of regulatory trends and assess their impact on company strategy. Advance partner relationships by supplying information or co-developing Module 3 CMC for submissions.

Requirements

Advanced degree in life sciences, chemistry, or related field (PhD, PharmD, MS preferred)
8+ years of experience in CMC regulatory affairs within the biotechnology or pharmaceutical industry
Proven experience with regulatory submissions (INDs, DMFs) and FDA interactions
Familiarity with advanced manufacturing technologies and regulatory pathways for novel platforms
Strong understanding of GMP, ISO 9001, and quality systems
Experience with oligonucleotide therapeutics
Prior involvement with FDA Emerging Technologies Program or similar regulatory innovation initiatives
Knowledge of regulatory requirements for supporting third-party therapeutic developers

Responsibilities

Develop and implement CMC regulatory strategies for the ECO Synthesis platform and GMP siRNA manufacturing
Lead interactions with regulatory agencies, including ongoing discussions with the FDA Emerging Technologies Team
Drive efforts toward achieving FDA Advanced Manufacturing Technology Designation
Prepare and manage CMC sections of regulatory submissions including INDs, DMFs, and amendments
Support therapeutic developer customers by providing high-quality documentation for Module 3 of their INDs
Partner with Process Development, Quality, Manufacturing, and Business Development teams to ensure regulatory compliance
Provide regulatory guidance during the design and construction of the GMP manufacturing facility
Ensure alignment of regulatory documentation with ISO 9001 and future GMP standards

Benefits

Medical, Dental and Vision Insurance
401k with Company Match up to 4%
Company Equity
Generous Paid Time Off including 18 Company Holidays, Vacation, and Wellness Time
Annual Lifestyle Account for reimbursement of fitness programs, equipment and more
Employee Stock Purchase Program (ESPP)
Student Debt Program (Company Contribution to Loans)
Subsidized onsite lunch program and Onsite Gym Facilities