Senior CMC Regulatory Lead - Small Molecule (Remote)

Travere Therapeutics; United States; Hybrid; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to lead strategic regulatory activities for small molecule products, with emphasis on oral solids. You will partner across Pharmaceutical Development, Manufacturing, Quality, and Regulatory Operations to ensure compliant CMC development and successful submissions.

The role requires extensive IND through NDA experience, lifecycle management, and collaboration with internal teams and health authorities.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry or related field required.
• Advanced degree (MS, PhD, PharmD, or equivalent) preferred.
• 7+ years regulatory affairs experience with CMC background sought.
• Experience with small molecule products from IND through commercialization and lifecycle management.

Responsibilities

• Develop and implement CMC regulatory strategies for clinical development, registration, and lifecycle management of small molecules.
• Lead cross‑functional teams as the CMC regulatory lead, guiding product development and submissions.
• Coordinate with multiple functions to align CMC activities with regulatory timelines and objectives.
• Prepare and manage CMC regulatory submissions (INDs, CTAs, NDAs, MAAs, variations, annual reports).
• Support regulatory interactions with health authorities and life-cycle management activities.

Skills

CMC regulatory leadership

Cross-functional collaboration

Regulatory submissions

Oral solid dosage forms

IND through NDA experience

Education

Bachelor's degree in Pharmaceutical Sciences/related

Advanced degree preferred

Job description

Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to lead strategic regulatory activities for small molecule products, with emphasis on oral solids. You will partner across Pharmaceutical Development, Manufacturing, Quality, and Regulatory Operations to ensure compliant CMC development and successful submissions.

The role requires extensive IND through NDA experience, lifecycle management, and collaboration with internal teams and health authorities.