Regulatory Strategy Manager, Late-Stage Biotech (Remote)

Travere Therapeutics; Boston (MA); On-site; USD 116,000 - 151,000; Full time

Benefits offered by this job

Premium health benefits

Generous paid time off

Retirement plans with employer match

Job summary

Travere Therapeutics in the United States seeks a Regulatory Affairs Manager to provide regulatory leadership and support for late-stage development programs. This remote role involves collaborating with cross-functional teams and ensuring compliance with regulatory requirements.

Ideal candidates will have over 6 years of regulatory experience in the pharmaceutical or biotechnology industry, strong project management skills, and excellent communication abilities. The compensation package ranges from $116,000 to $151,000 annually.

Qualifications

• 6+ years of regulatory affairs experience in pharmaceutical or biotechnology.
• Experience with IND, CTA, and related regulatory submissions.
• Strong understanding of FDA, EMA, and ICH regulations.

Responsibilities

• Provide regulatory leadership and execution support for development programs.
• Coordinate preparation and submission of regulatory applications.
• Support Health Authority interactions and manage regulatory risks.

Skills

Regulatory knowledge

Cross-functional collaboration

Project management

Communication skills

Problem-solving skills

Education

Bachelor's degree in Life Sciences or related field

Advanced degree (MS, PharmD, PhD)

Tools

Regulatory documentation systems

Project management tools

Job description

Travere Therapeutics in the United States seeks a Regulatory Affairs Manager to provide regulatory leadership and support for late-stage development programs. This remote role involves collaborating with cross-functional teams and ensuring compliance with regulatory requirements.

Ideal candidates will have over 6 years of regulatory experience in the pharmaceutical or biotechnology industry, strong project management skills, and excellent communication abilities. The compensation package ranges from $116,000 to $151,000 annually.