Regulatory Strategy Manager, Late-Stage Biotech (Remote)

Travere Therapeutics; New York (NY); On-site; USD 116,000 - 151,000; 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 Manager in Regulatory Affairs to provide regulatory oversight for late-stage development programs. This role involves collaborating with cross-functional teams to ensure compliance and drive regulatory deliverables.

The ideal candidate will have a Bachelor's degree in Life Sciences and 6+ years of regulatory affairs experience, particularly in clinical-stage development. This is a full-time role based in New York with flexibility for remote work.

Qualifications

• 6+ years of regulatory affairs experience within the pharmaceutical or biotechnology industry.
• Experience supporting clinical-stage development programs.
• Strong understanding of FDA, EMA, ICH requirements.

Responsibilities

• Support global regulatory strategies for late-stage programs.
• Coordinate preparation of regulatory applications.
• Manage health authority interactions and documentation.

Skills

Regulatory knowledge

Cross-functional collaboration

Project management

Excellent communication

Education

Bachelor's degree in Life Sciences

Advanced degree (MS, PharmD, PhD)

Job description

Travere Therapeutics is seeking a Manager in Regulatory Affairs to provide regulatory oversight for late-stage development programs. This role involves collaborating with cross-functional teams to ensure compliance and drive regulatory deliverables.

The ideal candidate will have a Bachelor's degree in Life Sciences and 6+ years of regulatory affairs experience, particularly in clinical-stage development. This is a full-time role based in New York with flexibility for remote work.