Associate Director​/Director, CMC Regulatory Affairs

Associate Director/ Director, CMC Regulatory Affairs

Department: 58 - Tech Ops Management

Employment Type: Full Time

Location: Redwood City, CA

Compensation: $185,000 - $250,000 / year

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.

• Regulatory Strategy & Leadership
  • 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.
• Documentation & Submissions
  • 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.
• Cross-functional Collaboration
  • 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.
• Compliance & Quality
  • 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.

• Advanced degree in life sciences, chemistry, or related field (PhD, Pharm
  
  D, 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.

• 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.

• 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!