Regulatory Strategy Manager, Late-Stage Biotech (Remote)

Travere Therapeutics; Wichita (KS); On-site; USD 116,000 - 151,000; Full time

Benefits offered by this job

Health insurance

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics is looking for a Manager of Regulatory Affairs. This role is crucial for providing regulatory leadership and supporting late-stage development programs.

The successful candidate will work closely with cross-functional teams to coordinate regulatory submissions and manage compliance. Candidates should have a Bachelor's degree in Life Sciences and at least 6 years of experience in regulatory affairs.

Comprehensive benefits and a competitive compensation package are offered, with a target base pay range of $116,000 - $151,000.

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 programs.

Responsibilities

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

Skills

Regulatory knowledge

Cross-functional collaboration

Project management

Problem-solving skills

Education

Bachelor's degree in Life Sciences or related field

Advanced degree (MS, PharmD, PhD, or equivalent)

Job description

Travere Therapeutics is looking for a Manager of Regulatory Affairs. This role is crucial for providing regulatory leadership and supporting late-stage development programs.

The successful candidate will work closely with cross-functional teams to coordinate regulatory submissions and manage compliance. Candidates should have a Bachelor's degree in Life Sciences and at least 6 years of experience in regulatory affairs.

Comprehensive benefits and a competitive compensation package are offered, with a target base pay range of $116,000 - $151,000.