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Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

Position Summary:

The Senior Director, Commercial Regulatory Affairs is responsible for overseeing review of promotional and medical communication materials across the product portfolio.  In this role, the Senior Director will represent Regulatory Affairs at Promotional Review Committee and Medical Review Committee meetings and other commercial review teams.  The Senior Director is responsible for development of global core data sheet and initial package insert/summary of medicinal product characteristics.

Key accountabilities include providing promotional regulatory guidance and strategy to key internal stakeholders to advance the commercialization of novel compounds and life cycle development of assigned products and assuring compliance with global regulatory standards and commitments.

Responsibilities:

• Liaison responsibility on behalf of Regulatory Affairs for FDA advertising and promotion (Ad/Promo) issues and providing internal training as needed on FDA requirements.
• Provide global regulatory Ad/Promo insight and regulatory procedural expertise in line with applicable regulatory guidelines.
• Ensure accurate and timely compilation and submission of Ad/Promo documentation.

• Represent Regulatory Affairs at PRC team meetings including other assigned teams i.e. sub-teams, labeling and promotional reviews.
• Apply influence and negotiation skills to support development results and resolve issues.
• Direct and ensure effective execution of optimal strategies for labeling development.
• Ensure global regulatory compliance standards and commitments are met.
• Liaise with FDA/OPDP as needed for product portfolio.
• Establish global strategic consistency across regional regulatory submissions by contributing to and reviewing regional-specific technical strategic regulatory documentation.
• Effectively monitor and ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, ensuring compliance with appropriate regulations and guidelines.
• Develop SOPs and working instructions to ensure high performing commercial regulatory operations and effective review processes.
• Collaborate with key internal partners and other key stakeholders to support a globally effective organization.
• Drive new product labeling development and back up positioning for label negotiations strategy.
• Establish core data sheet materials, create standard procedures and oversee global compliance with established labeling conventions.
• Partner with marketing and technical operations in implementing new or revised labeling for commercial pharmaceutical products, including primary and secondary packaging, package inserts, and printed components for use with promotional materials.
• Hire and develop team members within commercial regulatory.

Education/Experience Requirements: 

• Bachelor’s Degree in Life Science or other related discipline.  Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered. 
• Minimum of 12 years’ regulatory experience in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 8-10 years’ experience in a regulatory leadership role.
• Demonstrated track record of successful approval and launches is required. Prior regulatory agency liaison experience is essential.
• Strong expertise and knowledge of the Ad/Promo regulations is required. Experience in drug safety, pharmacovigilance and/or risk management preferred.
• Strong understanding of US laws and procedures relating to drug market authorizations, European Union a plus.

Additional Skills/Experience: 

• The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Strong professional experience in a similar role within the pharmaceutical industry, preferably small molecule pharmaceuticals. 
• Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Strong ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
• Strong influencing and negotiation skills.
• Successful record of creating and managing complex project plans, timelines, budgets, and critical paths.
• Ability to function effectively in a global scientific and cultural arena.
• Excellent team management skills, ability to lead, train and mentor team members at all levels.
• Work independently under general supervision. Exercises judgment within defined practices and policies.
• Ensure effective liaison with regulatory affairs counterparts to ensure aligned representation and decision making at assigned teams.
• Ability to travel 10-20% domestic and internationally. 
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.
• Travere will require proof of vaccination status to perform onsite, face to face work or to become employed.

COVID-19 VACCINATION REQUIREMENT

Where permitted, the Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment unless an exemption or accommodation is available and approved. Being fully vaccinated means that an individual is at least two weeks past their final dose of an authorized COVID-19 vaccine regimen and may include the individual obtaining vaccination boosters at certain intervals. Where permitted, as a condition of employment, final candidates will be required to provide proof of their COVID-19 vaccination unless an exemption or accommodation is available and approved. View the candidate COVID-19 vaccination policy webpage for information about the exemption or accommodation process for final candidates.