Remote CMC Regulatory Lead, Biologics

Regulatory Jobs; San Diego (CA); On-site; USD 132,000 - 172,000; Full time

Job summary

Travere Therapeutics seeks a Senior Manager, CMC Regulatory Affairs to lead global CMC regulatory strategies for biologic products across development and commercialization. The role collaborates with operations, development, QA, and regulatory teams to drive submissions and approvals.

The ideal candidate has 7+ years in regulatory affairs, strong experience with biologics, and a track record in global submissions and health authority interactions, supporting rare-disease programs.

Qualifications

• Bachelor's degree in biology/biotechnology/biochemical/chemical field or related
• Advanced degree (MS/PhD/ PharmD) preferred
• 7+ years Regulatory Affairs experience in biotech/pharma
• Experience with biologics development programs and Phase 3/late-stage
• Experience leading global regulatory submissions (BLAs/NDAs/MAAs/CTAs/INDs/IMPDs)
• Experience with Health Authority interactions and lifecycle management

Responsibilities

• Lead global CMC regulatory strategies for biologic products
• Manage regulatory submissions and health authority interactions
• Provide regulatory guidance across development, process development, and manufacturing
• Collaborate with cross-functional teams to align CMC plans with regulatory requirements
• Support lifecycle management and post-approval changes

Skills

CMC Regulatory Affairs

Biologics

Regulatory strategy

Global submissions

Cross-functional leadership

Education

Bachelors in a scientific discipline

Advanced degree preferred

Job description

Travere Therapeutics seeks a Senior Manager, CMC Regulatory Affairs to lead global CMC regulatory strategies for biologic products across development and commercialization. The role collaborates with operations, development, QA, and regulatory teams to drive submissions and approvals.

The ideal candidate has 7+ years in regulatory affairs, strong experience with biologics, and a track record in global submissions and health authority interactions, supporting rare-disease programs.