Regulatory Strategy Manager, Late-Stage Biotech (Remote)

Travere Therapeutics; Columbia (SC); On-site; USD 116,000 - 151,000; Full time

Benefits offered by this job

Premium health coverage

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics seeks a Manager, Regulatory Affairs to provide regulatory leadership for late-stage development programs. This role demands strong regulatory knowledge and collaboration with cross-functional teams to support submissions and major regulatory milestones.

Ideal candidates will have a Bachelor’s in Life Sciences or a related field, along with 6+ years of experience in regulatory affairs, particularly within the pharmaceutical or biotechnology industries. Benefits include comprehensive health coverage, financial and wellness programs, and competitive compensation ranging from $116,000 to $151,000.

Qualifications

• 6+ years of regulatory affairs experience in pharma or biotech.
• Experience with clinical-stage development programs.
• Knowledge of FDA, EMA, and ICH regulatory requirements.

Responsibilities

• Lead regulatory planning and execution for late-stage programs.
• Coordinate preparation and submission of INDs and CTAs.
• Collaborate with cross-functional teams for registration activities.

Skills

Regulatory knowledge

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor's degree in Life Sciences or related field

Advanced degree (MS, PharmD, PhD)

Job description

Travere Therapeutics seeks a Manager, Regulatory Affairs to provide regulatory leadership for late-stage development programs. This role demands strong regulatory knowledge and collaboration with cross-functional teams to support submissions and major regulatory milestones.

Ideal candidates will have a Bachelor’s in Life Sciences or a related field, along with 6+ years of experience in regulatory affairs, particularly within the pharmaceutical or biotechnology industries. Benefits include comprehensive health coverage, financial and wellness programs, and competitive compensation ranging from $116,000 to $151,000.