Associate Director/ Director, CMC Regulatory Affairs

Codexis Inc•Redwood City, CA

1d•$185,000 - $250,000

About The Position

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 will be instrumental in advancing our engagement with the FDA Emerging Technologies Program, supporting our pursuit of an FDA Advanced Manufacturing Technology Designation, and preparing for GMP manufacturing and regulatory submissions including Drug Master Files (DMFs) and IND support. This role will also be critical to advancing our partner relationships as we supply information and/or co-develop Module 3 CMC information for partner 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.
Excellent communication, leadership, and project management skills.

Nice To Haves

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.
Ensure alignment of regulatory documentation with ISO 9001 and future GMP standards.
Partner with Process Development, Quality, Manufacturing, and Business Development teams to ensure regulatory compliance and readiness.
Provide regulatory guidance during the design and construction of the GMP manufacturing facility.
Ensure regulatory compliance with evolving FDA and global regulatory expectations for advanced manufacturing technologies.
Maintain awareness of regulatory trends and proactively assess their impact on company strategy.

Benefits

Medical, Dental and Vision Insurance
Basic Life, AD&D, Short- and Long-Term Disability Insurance
401k with Company Match up to 4%
Company Equity
Generous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness Time
Annual Lifestyle Account for reimbursement of fitness programs, equipment and more
Employee Stock Purchase Program (ESPP)
Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare)
Student Debt Program (Company Contribution to Loans)
Mental Health Wellness Program
Subsidized onsite lunch program
Onsite Gym Facilities
Paid Parental Leave
And More!