Senior CMC Regulatory Lead - Small Molecule Drugs (Remote)

Travere Therapeutics; Washington (District of Columbia); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health insurance

Retirement plan with company match

Generous PTO

Job summary

Travere Therapeutics, located in San Diego, seeks an Associate Director, CMC Regulatory Affairs, to provide strategic and operational leadership for CMC activities across development and commercial programs, with emphasis on oral solid dosage forms.

The role leads global regulatory submissions, Health Authority interactions, and lifecycle management, collaborating with Development, Manufacturing, Quality, Analytical Development, Supply Chain, and Regulatory Operations to align plans with

Qualifications

• 8+ years of Regulatory Affairs experience in pharma/biotech.
• Experience with small molecule from IND through commercialization.
• Strong leadership and cross-functional collaboration.
• Experience preparing global regulatory submissions (INDs, NDAs, MAAs, amendments).

Responsibilities

• Develop global CMC regulatory strategies for small molecule products.
• Lead cross-functional teams to ensure timely regulatory submissions.
• Prepare and review CMC documentation including INDs, CTAs, NDAs, MAAs and variations.
• Provide regulatory guidance for formulation development, manufacturing, analytics and lifecycle management.
• Coordinate Health Authority meetings and responses to regulatory questions.
• Support inspection readiness and post-approval lifecycle activities.

Skills

CMC Regulatory

Regulatory Submissions

Cross-functional Leadership

FDA/EMA experience

Oral Solid Dosage Forms

Education

Bachelor's degree in Pharmaceutical Sciences or related

Advanced degree preferred

Job description

Travere Therapeutics, located in San Diego, seeks an Associate Director, CMC Regulatory Affairs, to provide strategic and operational leadership for CMC activities across development and commercial programs, with emphasis on oral solid dosage forms.

The role leads global regulatory submissions, Health Authority interactions, and lifecycle management, collaborating with Development, Manufacturing, Quality, Analytical Development, Supply Chain, and Regulatory Operations to align plans with