Senior CMC Regulatory Lead – Biologics (Remote)

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

Benefits offered by this job

Comprehensive 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 regulatory strategies and submissions for biologic products. The role demands extensive experience in regulatory affairs, especially for biologics, focusing on late-stage development.

Located in Washington D.C., this position encompasses collaboration across teams, ensuring alignment with global regulatory standards. The ideal candidate will have strong leadership skills and a comprehensive understanding of the biotechnology field.

Qualifications

• 7+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry.
• Demonstrated experience supporting biologics development programs.
• Significant experience supporting Phase 3 and late-stage development programs.

Responsibilities

• Develop and implement global CMC regulatory strategies for biologic products.
• Lead preparation and submission of CMC documentation for global regulatory filings.
• Evaluate regulatory impact of manufacturing changes related to biologics.

Skills

Regulatory Affairs Experience

Biologic Drug Development

Strategic Leadership

CMC Regulatory Submissions

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS, PharmD, PhD)

Job description

Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to lead regulatory strategies and submissions for biologic products. The role demands extensive experience in regulatory affairs, especially for biologics, focusing on late-stage development.

Located in Washington D.C., this position encompasses collaboration across teams, ensuring alignment with global regulatory standards. The ideal candidate will have strong leadership skills and a comprehensive understanding of the biotechnology field.