Senior CMC Regulatory Affairs Lead (Remote)

Travere Therapeutics; Columbus (OH); Remote; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategies for small molecule products, focusing on oral solid dosage forms. You will collaborate with Development, Manufacturing, Quality, and Regulatory Operations to ensure successful filings and lifecycle management.

The role requires 8+ years in regulatory affairs with CMC emphasis, and experience with FDA, EMA, GCC, and PMDA interactions.

Qualifications

• 8+ years of Regulatory Affairs experience with significant CMC experience.
• Experience supporting small molecule drug products from IND through commercialization.
• Strong coordination with multiple functions to align regulatory plans.

Responsibilities

• Lead global CMC regulatory submissions and health authority interactions.
• Develop and implement global CMC regulatory strategies for development and lifecycle management.
• Provide regulatory guidance for process validation, manufacturing site changes, and technology transfers.
• Prepare, review, and submit CMC documentation including INDs, NDAs, and variations.
• Ensure compliance with regional regulatory expectations and respond to questions from authorities.

Skills

CMC Regulatory Strategy

Regulatory Submissions

Cross-functional Leadership

Education

Bachelor's degree in Pharmaceutical Sciences

Advanced degree (MS/PhD/PharmD)

Job description

Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategies for small molecule products, focusing on oral solid dosage forms. You will collaborate with Development, Manufacturing, Quality, and Regulatory Operations to ensure successful filings and lifecycle management.

The role requires 8+ years in regulatory affairs with CMC emphasis, and experience with FDA, EMA, GCC, and PMDA interactions.