Senior CMC Regulatory Lead – Biologics (Remote)

Travere Therapeutics; Boston (MA); On-site; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health benefits

Generous paid time off

Retirement plans with employer match

Job summary

Travere Therapeutics is looking for a Senior Manager in CMC Regulatory Affairs to provide strategic regulatory leadership in supporting biologics. This role involves developing global CMC regulatory strategies, managing submissions, and working closely with cross-functional teams.

The ideal candidate will have extensive experience in Regulatory Affairs within the biotechnology sector, particularly with a focus on biologics and rare diseases. This position allows for a collaborative work environment while being largely remote.

Qualifications

• 7+ years of Regulatory Affairs experience in biotech or pharma industry.
• Significant CMC Regulatory Affairs experience with biologics.
• Experience with global regulatory submissions including BLAs and INDs.

Responsibilities

• Lead global CMC regulatory strategies for biologics.
• Manage Health Authority interactions related to CMC topics.
• Develop mitigation strategies and regulatory recommendations.

Skills

Regulatory Affairs

Biologics development

CMC regulatory submissions

Health Authority interactions

Team collaboration

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS, PharmD, PhD preferred)

Job description

Travere Therapeutics is looking for a Senior Manager in CMC Regulatory Affairs to provide strategic regulatory leadership in supporting biologics. This role involves developing global CMC regulatory strategies, managing submissions, and working closely with cross-functional teams.

The ideal candidate will have extensive experience in Regulatory Affairs within the biotechnology sector, particularly with a focus on biologics and rare diseases. This position allows for a collaborative work environment while being largely remote.