Senior Director, Commercial Regulatory Affairs

Travere Therapeutics Senior Director, Commercial Regulatory Affairs Denver, Colorado Apply Now

Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates.

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.

Position Summary : The Senior Director, Commercial Regulatory Affairs is responsible for overseeing the 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 the development of global core data sheets 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 lifecycle 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.
• 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 7 years' experience in a regulatory leadership role.

Demonstrated track record of successful approvals 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.

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