Director, Global CMC Regulatory Affairs

Enigma Search; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Enigma Search in the United States is seeking a Director, Regulatory CMC to lead global regulatory activities for small molecules and monoclonal antibodies, shaping strategies for accelerated development and successful product registrations.

The role partners with CMC, Quality, and Manufacturing teams to prepare submissions (NDA, BLA, MAAs), maintain the CTD, ensure regulatory readiness, and oversee changes across regions from development through commercialization.

Qualifications

• BS or MS in Chemistry, Biology, Pharmacy or related field; PhD/PharmD preferred.
• Minimum 10 years biopharma experience with 7+ in CMC regulatory affairs.
• Experience supporting major marketing applications (NDA/BLA/MAA).
• Strong knowledge of GMP, ICH, and global regulatory requirements.

Responsibilities

• Create global CMC regulatory strategies for clinical development and product registrations.
• Lead preparation of CMC documentation for regulatory submissions and responses.
• Collaborate with cross-functional teams and engage health authorities worldwide.

Job description

Enigma Search in the United States is seeking a Director, Regulatory CMC to lead global regulatory activities for small molecules and monoclonal antibodies, shaping strategies for accelerated development and successful product registrations.

The role partners with CMC, Quality, and Manufacturing teams to prepare submissions (NDA, BLA, MAAs), maintain the CTD, ensure regulatory readiness, and oversee changes across regions from development through commercialization.