Department:
607000 Regulatory - TTSG
Location:
Rapperswil-Jona (SG), 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.
The Associate Director, RoW Regulatory Affairs is responsible for providing technical regulatory leadership and in-depth expertise in establishing and executing regulatory strategies and leading interactions with internal stakeholders, international partners and regulatory authorities to advance development of novel compounds in the orphan/rare disease space. This position will be responsible for lifecycle management of assigned products. This position will also plan and coordinate regulatory submissions necessary to support clinical development, registration and commercialization plans to meet global regulatory requirements and company goals.
At Travere, our mission is to identify, develop and deliver life-changing therapies to people living with rare diseases to help them achieve the best possible therapeutic outcomes. Giving patients a chance, providing hope, is what drives us. Travere recognizes that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of patients. Our work is rewarding, professionally and personally because we are making a difference and we are passionate about what we do. We are headquartered in San Diego, CA with additional offices in Dublin, Ireland and Rapperswil, SG, Switzerland.
Responsibilities:
- As the principal RoW Regulatory Liaison, provide regulatory strategic insight and procedural expertise in line with applicable regulatory guidelines for international markets.
- Lead the development and implementation of international regulatory strategies; manage regulatory activities and timelines for assigned projects and programs across product life cycles.
- Develop and maintain regulatory and technical sections of pre-approval, MAA and post-approval submissions ensuring compliance with ICH and local requirements, as well as company policies and procedures.
- 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.
- Establish and maintain strong relationships with International partner companies, vendors, CROs and Regulatory Agencies.
- Ensure effective collaboration with regulatory affairs counterparts to ensure aligned representation and decision making at assigned teams.
- Provide regulatory guidance and expertise to internal customers including nonclinical, clinical operations/development, medical affairs, medical writing, biostatistics and program teams (Strategy Teams and Satellite Sub-Teams) and apply influence and negotiation skills to drive international registrations.
- Ensure applicable international regulatory requirements are considered and appropriately incorporated into all programs, ensuring compliance with appropriate regulations and guidelines. Identify gaps and challenges and propose options to address them.
- Research and analyze applicable regulatory information and provide intelligence information to the team; maintain current regulatory knowledge.
- Support new Business Development initiatives, including due diligence activities and technical regulatory assessments, as needed.
- Prepare and implement new SOPs and/or changes to current SOPs.
- Other relevant activities as assigned by the Executive Director of European/RoW 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 regulatory affairs experience in the pharmaceutical or biotechnology industry or government health agency.
- Demonstrated track record of successful approvals from international regulatory agencies 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 International guidelines relevant to product development and submission of pre/post authorization applications and ability to assess the impact of these requirements to the business.
- Extensive track record and experience in drafting and reviewing regulatory submissions (CTA, MAAs, Variations).
- Strong leadership, interpersonal and organizational skills and excellent verbal and written communication skills are required.
- Ability to manage various projects, solve problems, deliver on commitments and work with multidisciplinary teams.
- Independent, self-starting individual with a demonstrated ability to thrive in smaller, biotech environment is required.
- Experience with document management/archival systems (Veeva Vault experience preferred)
- Some flexibility in hours will be required for participating in international teleconferences.
- Ability to travel 10% domestic and internationally.
- Embodiment of Travere’s Core Values: Courage, Community Spirit, Patient Focus and Teamwork
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to
accommodations@travere.com
. 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.
