Regulatory Strategy Manager, Late-Stage Biotech (Remote)

Travere Therapeutics; Detroit (MI); 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 is seeking a Manager, Regulatory Affairs to support regulatory leadership for late-stage development programs. This role requires collaboration with cross-functional teams to ensure compliance and facilitate successful regulatory submissions.

The ideal candidate will possess a Bachelor's degree in Life Sciences with over 6 years of experience in regulatory affairs. The position offers a competitive salary range of $116,000 to $151,000 annually and includes comprehensive benefits.

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.

Responsibilities

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

Skills

Regulatory knowledge

Cross-functional collaboration

Project management

Excellent communication skills

Problem-solving

Education

Bachelor's degree in Life Sciences or related field

Advanced degree (MS, PharmD, PhD)

Job description

Travere Therapeutics is seeking a Manager, Regulatory Affairs to support regulatory leadership for late-stage development programs. This role requires collaboration with cross-functional teams to ensure compliance and facilitate successful regulatory submissions.

The ideal candidate will possess a Bachelor's degree in Life Sciences with over 6 years of experience in regulatory affairs. The position offers a competitive salary range of $116,000 to $151,000 annually and includes comprehensive benefits.