Regulatory Strategy Manager, Late-Stage Biotech (Remote)

Travere Therapeutics; Minneapolis (MN); On-site; USD 116,000 - 151,000; Full time

Benefits offered by this job

Premium health insurance

Generous paid time off

Retirement plans with employer match

Job summary

Travere Therapeutics is seeking a Manager for Regulatory Affairs to provide leadership in regulatory execution for late-stage development programs. The role involves working closely with cross-functional teams to support regulatory planning and submission execution.

The ideal candidate will have over 6 years of experience in regulatory affairs within the pharmaceutical industry, understanding of FDA and EMA requirements, and exceptional communication skills.

Comprehensive benefits and a competitive compensation package are offered.

Qualifications

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

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.

Skills

Regulatory knowledge

Cross-functional collaboration

Project management

Problem-solving skills

Communication skills

Education

Bachelor's degree in Life Sciences or related field

Advanced degree (MS, PharmD, PhD)

Job description

Travere Therapeutics is seeking a Manager for Regulatory Affairs to provide leadership in regulatory execution for late-stage development programs. The role involves working closely with cross-functional teams to support regulatory planning and submission execution.

The ideal candidate will have over 6 years of experience in regulatory affairs within the pharmaceutical industry, understanding of FDA and EMA requirements, and exceptional communication skills.

Comprehensive benefits and a competitive compensation package are offered.