Senior CMC Regulatory Lead - Small Molecule

Travere Therapeutics; Boston (MA); Remote; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health benefits

Stock options

Job summary

Travere Therapeutics in the United States is seeking an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for small molecule products, focusing on oral solid dosage forms and lifecycle management.

The role serves as the primary CMC regulatory lead on cross-functional teams, collaborating with Regulatory Operations, Manufacturing, Quality, and Clinical Development to drive submissions with global authorities including FDA, EMA, GCC, and PMDA.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences or related field required; advanced degree preferred.
• 8+ years in Regulatory Affairs with strong CMC experience.
• Experience with IND through NDA and post-approval lifecycle.
• Experience communicating with global Health Authorities (FDA, EMA, PMDA).

Responsibilities

• Lead global CMC regulatory submissions and health authority interactions.
• Develop and implement global CMC strategies for development and commercialization.
• Collaborate with cross-functional teams to align CMC development with regulatory requirements.
• Support inspections readiness and lifecycle management activities.

Skills

CMC Regulatory

Global Submissions

Health Authority Interactions

Oral Solid Dosage

Regulatory Leadership

Education

Bachelor's degree in Pharmaceutical Sciences

MS/PhD or PharmD preferred

Job description

Travere Therapeutics in the United States is seeking an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for small molecule products, focusing on oral solid dosage forms and lifecycle management.

The role serves as the primary CMC regulatory lead on cross-functional teams, collaborating with Regulatory Operations, Manufacturing, Quality, and Clinical Development to drive submissions with global authorities including FDA, EMA, GCC, and PMDA.