Regulatory Strategy Manager, Late-Stage Biotech (Remote)

Travere Therapeutics; Providence (RI); 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 looking for a Manager, Regulatory Affairs to lead regulatory strategy and execution for late-stage development programs. The role involves collaborating with cross-functional teams and ensuring compliance with regulatory requirements.

The ideal candidate will have over 6 years of experience in regulatory affairs, specifically in the pharmaceutical or biotechnology industry, along with a Bachelor's degree in Life Sciences. This position offers a competitive compensation package and flexibility for remote work.

Qualifications

• 6+ years of regulatory affairs experience within the pharmaceutical or biotechnology industry.
• Experience supporting clinical-stage development programs and global regulatory submissions.
• Strong understanding of drug development and regulatory requirements for late-stage development.

Responsibilities

• Support implementation of global regulatory strategies for late-stage development programs.
• Represent Regulatory Affairs on cross-functional project teams.
• Coordinate preparation and submission of regulatory applications.
• Lead preparation of regulatory documents for major submission milestones.
• Identify regulatory risks and support development of mitigation strategies.

Skills

Regulatory knowledge

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor's degree in Life Sciences

Advanced degree (MS, PharmD, PhD)

Job description

Travere Therapeutics is looking for a Manager, Regulatory Affairs to lead regulatory strategy and execution for late-stage development programs. The role involves collaborating with cross-functional teams and ensuring compliance with regulatory requirements.

The ideal candidate will have over 6 years of experience in regulatory affairs, specifically in the pharmaceutical or biotechnology industry, along with a Bachelor's degree in Life Sciences. This position offers a competitive compensation package and flexibility for remote work.