Department:
607000 Regulatory - TTSG
Location:
St Gallen - Switzerland
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 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 and provide intelligence information to the team; maintain current regulatory knowledge.
- Other relevant activities as assigned by the Executive Director of Regulatory Affairs.
Education/Experience Requirements:
- Bachelor’s Degree/Science degree in a biological science is required. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.
- At least 8 years of progressive regulatory affairs experience in the pharmaceutical or biotechnology industry or government health agency, including demonstrated leadership of complex development programs and strategic interactions with major health authorities.
- Demonstrated track record of successful approvals from a major regulatory agency is required. Prior regulatory agency liaison experience is essential.
- Solid expertise and knowledge of the drug development process is required.
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.
- Experience in interpretation and application of ICH and EU guidelines relevant to product development and submission of pre/post authorization applications.
- Extensive track record and experience in drafting and reviewing regulatory submissions (CTA, MAAs, Variations).
Additional Skills/Experience:
- Embodiment of Travere’s Core Values: Courage, Community Spirit, Patient Focus and Teamwork
- Strong professional experience in a similar role within the pharmaceutical industry.
- 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 travel 10% domestically and internationally.
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [email protected]. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.
