Global CMC Regulatory Lead - Small Molecule (Remote)

Travere Therapeutics

Denver (CO)

Remote

USD 150,000 - 195,000

Full time

5 days ago

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Benefits offered by this job

Health benefits

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics seeks an Associate Director of CMC Regulatory Affairs to provide strategic regulatory leadership for CMC activities across development and commercial programs. You will lead global submissions, interact with Health Authorities, and guide lifecycle management for small molecule products, with a focus on oral solid dosage forms.

The role requires extensive experience from IND through NDA, collaboration with multiple functions, and readiness to travel up to 10% domestically and

Qualifications

8+ years in Regulatory Affairs with significant CMC experience.
Strong experience with small molecule products from IND through commercialization.
Experience leading or supporting Health Authority interactions related to CMC topics.

Responsibilities

Develop and implement global CMC regulatory strategies to support clinical development, registration, and lifecycle management.
Serve as the CMC Regulatory lead on cross-functional program teams.
Coordinate cross-functional contributions to global CMC regulatory submissions and ensure regulatory timelines.

Skills

CMC regulatory leadership

Global regulatory submissions

Regulatory strategy

Cross-functional collaboration

IND to NDA experience

Oral solid dosage expertise

FDA/EMA/PMDA experience

Education

Bachelor's degree in Pharmaceutical Sciences or related

MS/PhD/PharmD preferred

Job description

The role requires extensive experience from IND through NDA, collaboration with multiple functions, and readiness to travel up to 10% domestically and

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