Regulatory Strategy Manager, Late-Stage Biotech (Remote)

Travere Therapeutics; Manchester (NH); On-site; USD 116,000 - 151,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics is seeking a Manager, Regulatory Affairs to provide regulatory leadership for late-stage development programs. This position involves implementing global regulatory strategies, engaging with cross-functional teams, and supporting interactions with Health Authorities.

The ideal candidate will have at least 6 years of regulatory experience in the pharmaceutical industry and be knowledgeable about FDA and EMA regulations. A Bachelor's degree in Life Sciences is required, with advanced degrees preferred. This role offers a competitive compensation package and significant benefits.

Qualifications

• 6+ years of regulatory affairs experience within the pharmaceutical or biotechnology industry.
• Experience supporting clinical-stage development programs and global regulatory submissions.
• Working knowledge of FDA, EMA, ICH, and other applicable global regulatory requirements.

Responsibilities

• Support implementation of global regulatory strategies for late-stage development programs.
• Coordinate preparation and submission of regulatory applications, including INDs and CTAs.
• Manage activities performed by regulatory consultants and external vendors.

Skills

Regulatory knowledge

Cross-functional collaboration

Project management

Clinical-stage development

Regulatory submissions

Education

Bachelor's degree in Life Sciences

Advanced degree (MS, PharmD, PhD)

Job description

Travere Therapeutics is seeking a Manager, Regulatory Affairs to provide regulatory leadership for late-stage development programs. This position involves implementing global regulatory strategies, engaging with cross-functional teams, and supporting interactions with Health Authorities.

The ideal candidate will have at least 6 years of regulatory experience in the pharmaceutical industry and be knowledgeable about FDA and EMA regulations. A Bachelor's degree in Life Sciences is required, with advanced degrees preferred. This role offers a competitive compensation package and significant benefits.