Director, Regulatory Affairs CMC

Position Summary

Director, Regulatory CMC. Hybrid role (office ~3 days/week) in San Diego, CA;
San Francisco, CA; or Princeton, NJ.

• Manage CMC regulatory affairs for marketed products and compounds in development (US and ex-US).
• Coordinate with R&D, Pharmaceutical Development, Manufacturing, Quality, and other functions to develop/implement CMC regulatory strategy.
• Lead timely preparation of CMC sections of INDs, CTAs, NDAs, MAAs, and amendments for global submissions.
• Serve as regulatory CMC expert and point of contact for agencies on CMC development, registration, and lifecycle activities.
• Provide CMC guidance/risk identification and mitigation for development teams.
• Ensure CMC compliance with applicable regulations/guidelines.
• Evaluate manufacturing processes/changes; assess regulatory implications; support implementation.
• Maintain knowledge of relevant regulations and determine applicability.

• BS in life science (or related); equivalent education/experience considered.
• ~10 years progressively responsible CMC Regulatory Affairs (small molecules), including 5 years in management.
• Knowledge of global regulatory CMC requirements.
• Experience preparing/submitting CMC components of IND/CTA, briefing packages, NDA, and ex-US MAA.
• Cross-functional collaboration; strong organization; detail-oriented; deadline management.
• Negotiation/influencing skills; initiative; ability to work with limited supervision.
• Willingness to travel domestically/internationally.

• Discretionary bonus and equity awards.
• Salary range: $189,700–$237,100.
• Medical/dental/vision; life/disability/travel/EAP; 401(k) match (1:1 up to 5%); ESPP; 15+ vacation; 13–15 paid holidays; 10 paid sick days; paid parental leave; tuition assistance.