Executive Director, Regulatory Affairs

Travere Therapeutics - Grove City, OH

Full-time - Senior

Remote - Grove City, OH

Administrative and Support Services

About the position

The Executive Director, Regulatory Affairs at Travere Therapeutics is responsible for developing and executing global regulatory strategies for innovative drug development in rare diseases. This role ensures compliance with local regulations while facilitating fast market access for new therapies. The position involves collaboration with various stakeholders and regulatory agencies to maintain product compliance and support the company's mission of delivering life-changing therapies to patients.

Responsibilities

• Key member of the Regulatory and back-up for program Leadership teams.
• Develop, recommend, execute strategic and operational regulatory direction and mentorship on projects.
• Utilize regulatory tools to develop accelerated global regulatory approval strategies using novel endpoints, biomarkers, or alternative clinical trial data.
• Manage interface with outside regulatory agencies and trade associations, advising senior management on global regulatory strategy.
• Accountable for preparation, submission, and maintenance of product-specific dossiers (IND/CTA, NDA/MAA) per local country requirements.
• Negotiate with regulatory authorities and respond to queries during the development and review process.
• Ensure annual licenses, registrations, listings, and patent information are maintained.
• Ensure compliance with product post-marketing approval requirements.
• Ensure labeling, publications, advertising, and promotional items are compliant with regulatory requirements.
• Assess regulatory impacts associated with changes made in product development.
• Collaborate with internal stakeholders to define or develop registration documents to support global development actions.
• Provide leadership to global regulatory strategy teams, sharing knowledge and expertise on strategic thinking and regulatory precedence reviews.
• Participate in product development and acquisition assessment teams to evaluate potential Regulatory Strategies.
• Formulate department procedures as required.
• Recruit, develop, and manage an effective regulatory team.

Requirements

• Extensive experience in regulatory affairs within the biopharmaceutical industry, particularly in rare diseases.
• Proven track record of successful regulatory submissions and interactions with health authorities.
• Strong understanding of global regulatory requirements and processes.
• Excellent leadership and team management skills.
• Ability to develop and execute strategic regulatory plans.

Nice-to-haves

• Experience with innovative drug development and accelerated approval pathways.
• Familiarity with clinical trial design and regulatory tools.
• Strong negotiation skills with regulatory authorities.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Flexible scheduling options
• Professional development opportunities
• Paid holidays