Manager, Regulatory Affairs Strategy

Travere Therapeutics

Manager of Regulatory Affairs providing regulatory leadership for late-stage development programs at Travere Therapeutics. Collaborating with teams to support regulatory planning and submission execution.

Posted 6/27/2026full-timeSan Diego • California • 🇺🇸 United StatesMid-LevelSenior💰 $116,000 - $151,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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The ideal candidate must demonstrate strong regulatory leadership and project management skills, effectively managing regulatory submissions and interactions with Health Authorities while ensuring compliance with global regulatory requirements.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsGlobal Regulatory StrategiesIND SubmissionCTA SubmissionRegulatory PlanningSubmission ExecutionHealth Authority InteractionsDrug DevelopmentRegulatory RequirementsProject Management

Soft Skills

Organizational SkillsLeadershipCollaborationCommunicationProblem-Solving

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryFDAEMAICHClinical-Stage DevelopmentRegulatory MilestonesLate-Stage Development ProgramsRegulatory ConsultantsExternal Vendors

About the role

Key responsibilities & impact

Provide regulatory leadership and execution support for late-stage development programs
Contribute to the implementation of global regulatory strategies
Support regulatory planning, submission execution, Health Authority interactions, and major regulatory milestones
Manage activities performed by regulatory consultants and external vendors

Requirements

What you’ll need

Bachelor's degree in Life Sciences or related field required
6+ years of regulatory affairs experience within the pharmaceutical or biotechnology industry
Experience supporting clinical-stage development programs and global regulatory submissions
Working knowledge of FDA, EMA, ICH, and other applicable global regulatory requirements
Experience preparing or supporting IND, CTA, and related regulatory submissions
Strong understanding of drug development and regulatory requirements for late-stage development programs
Strong project management and organizational skills

Benefits

Comp & perks

premium health
financial offerings
work-life and well-being offerings
wellness and employee support programs
life insurance
disability
retirement plans with employer match
generous paid time off