Associate Director, Regulatory Affairs, EU & RoW

Department:

607000 Regulatory - TTSG Location:

St Gallen - SwitzerlandBe 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 Associate Director, Regulatory Affairs (EU/RoW) provides strategic and technical regulatory leadership for the development, registration, commercialization, and lifecycle management of novel therapies in the orphan and rare disease space. Serving as the principal regulatory representative for assigned programs across the European Union and Rest of World regions, this role is responsible for developing and executing regional regulatory strategies, leading interactions with regulatory authorities, partners, and internal stakeholders, and ensuring successful regulatory outcomes aligned with development, registration, and commercialization objectives.

The position drives cross-functional collaboration, influences key business and development decisions, and plans and coordinates regulatory submissions required to support clinical development, marketing authorization, and ongoing product lifecycle activities in accordance with global regulatory requirements and company goals.

Responsibilities:

• As the principal regional liaison, provide regulatory strategic insight and procedural expertise in line with applicable regulatory guidelines.
• Establish regulatory objectives, strategic priorities and regional regulatory plans for assigned programs, driving key decisions that influence development, registration and lifecycle management activities.
• Accountable for ensuring regulatory strategies and activities support achievement of program milestones and business objectives while proactively identifying and mitigating regulatory risks.
• Independently assess regulatory risks, evaluate strategic options and make recommendations that may significantly impact development timelines, operational priorities and commercial objectives.
• Provide leadership and direction across matrixed cross-functional teams, driving alignment on regulatory strategy, risk assessment and critical development decisions.
• Influence senior leaders and key stakeholders across multiple functions to achieve strategic regulatory objectives and resolve complex development and registration challenges.
• Serve as the primary regional regulatory representative and decision-maker for assigned programs, providing strategic leadership during health authority interactions and negotiations.
• Develop and maintain regulatory and technical sections of pre-approval, MAA and post-approval submissions ensuring compliance with applicable requirements.
• Oversee preparation, review and submission of high-quality clinical trial, pre/post authorization regulatory documents and responses to questions to regulatory agencies and ensure submissions are complete, properly formatted and comply with applicable regulatory requirements and timelines.
• Research and analyze applicable regulatory information