Regulatory Strategy Manager, Late-Stage Biotech (Remote)

Travere Therapeutics; Columbus (OH); On-site; USD 116,000 - 151,000; Full time

Benefits offered by this job

Premium health and financial benefits

Wellness and employee support programs

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics in Columbus, Ohio, is seeking a Manager, Regulatory Affairs to lead regulatory efforts for late-stage development programs. This pivotal role involves collaboration with cross-functional teams and ensuring compliance with regulatory standards while driving major regulatory milestones.

The successful candidate will have at least 6 years of experience in regulatory affairs, especially in the pharmaceutical industry, and will have a strong grasp of FDA and other global requirements. The role allows for remote work, complemented by a robust compensation and benefits package.

Qualifications

• 6+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry.
• Experience supporting clinical-stage development programs.
• Strong understanding of FDA, EMA, ICH, and 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 affairs experience

Strong communication skills

Project management

FDA knowledge

Understanding of drug development

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred (MS, PharmD, PhD)

Job description

Travere Therapeutics in Columbus, Ohio, is seeking a Manager, Regulatory Affairs to lead regulatory efforts for late-stage development programs. This pivotal role involves collaboration with cross-functional teams and ensuring compliance with regulatory standards while driving major regulatory milestones.

The successful candidate will have at least 6 years of experience in regulatory affairs, especially in the pharmaceutical industry, and will have a strong grasp of FDA and other global requirements. The role allows for remote work, complemented by a robust compensation and benefits package.