Remote Senior Manager, CMC Regulatory Affairs

Travere Therapeutics; Columbia (SC); On-site; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health insurance

401(k) with employer match

Well-being and work-life programs

Job summary

Travere Therapeutics in San Diego, remote-friendly, seeks a Senior Manager of CMC Regulatory Affairs to lead regulatory strategy for small molecule products across development and commercialization. You will work with Development, Technical Operations, Manufacturing, Quality, and Regulatory Operations to align CMC plans with regulatory requirements and business objectives.

The role emphasizes extensive experience with oral solid dosage forms, process validation, analytical methods, and lifecycle

Qualifications

• Bachelor's degree required in a pharmaceutical science or related field.
• Advanced degree preferred.
• 7+ years Regulatory Affairs experience with CMC focus.

Responsibilities

• Develop and implement CMC regulatory strategies to support clinical development and lifecycle management.
• Lead cross-functional teams to align CMC plans with regulatory requirements.
• Prepare and manage CMC submissions and regulatory filings (INDs, CTAs, NDAs, etc.).
• Provide regulatory guidance for manufacturing changes, site transfers, and lifecycle activities.
• Support inspection readiness and communications with Health Authorities.

Skills

CMC Regulatory Strategy

Cross-functional leadership

Regulatory submissions

Regulatory strategy

Lifecycle management

Oral solid dosage forms

Regulatory guidance

FDA/EMA/PMDA regulatory

Project management

Regulatory risk assessment

Education

Bachelor's degree in Pharmaceutical Sciences/C Chemistry/ related

Advanced degree preferred (MS/PhD/ PharmD)

Tools

IND/CTA/NDAs submissions

CMC documentation preparation

Job description

Travere Therapeutics in San Diego, remote-friendly, seeks a Senior Manager of CMC Regulatory Affairs to lead regulatory strategy for small molecule products across development and commercialization. You will work with Development, Technical Operations, Manufacturing, Quality, and Regulatory Operations to align CMC plans with regulatory requirements and business objectives.

The role emphasizes extensive experience with oral solid dosage forms, process validation, analytical methods, and lifecycle