Strategic CMC Regulatory Lead for Small Molecule Drugs (Remote)

Travere Therapeutics; Providence (RI); On-site; 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 provide strategic regulatory leadership for small molecule drug products across development and commercialization. Lead CMC strategies, author Module 2/3, and coordinate cross-functional teams to meet submission timelines.

You will interact with Health Authorities, manage lifecycle changes, and support global regulatory activities. 7+ years of experience and strong leadership are required.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or related field.
• Advanced degree (MS, PhD, PharmD) preferred.
• 7+ years of Regulatory Affairs experience with strong CMC background.

Responsibilities

• Develop and implement CMC regulatory strategies for small molecule products.
• Lead CMC regulatory submissions and responses to Health Authority questions.
• Coordinate cross-functional contributions to align regulatory plans with business objectives.
• Provide regulatory oversight for analytical method development, validation, and lifecycle management.
• Serve as primary CMC representative for Health Authority meetings and inspections.

Skills

CMC Regulatory Affairs

Oral solid dosage forms

Leadership

Independent work

CMC submissions

Education

Bachelor's degree in Pharmaceutical Sciences

Advanced degree (MS/PhD/PharmD) preferred

Job description

Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership for small molecule drug products across development and commercialization. Lead CMC strategies, author Module 2/3, and coordinate cross-functional teams to meet submission timelines.

You will interact with Health Authorities, manage lifecycle changes, and support global regulatory activities. 7+ years of experience and strong leadership are required.