Manager, Regulatory Affairs - Europe

Job content

Department:

517000 Regulatory - TTIL

Location:

Rapperswil-Jona, St. Gallen, Switzerland, 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 Manager, European Regulatory Affairs is responsible for executing regulatory strategies and supporting interactions with internal stakeholders, 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, with a significant focus on clinical trial management. 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 seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast-paced environment and share in our mission to help others. We are headquartered in San Diego, CA with additional offices in Dublin, Ireland and Rapperswil, Switzerland.

Essential Functions:

• Contribute to the development and implementation of approved regulatory strategies; manage regulatory activities and timelines for assigned projects and programs.
• Develop and maintain regulatory and technical sections of regulatory 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, ensuring submissions are complete, properly formatted and comply with applicable regulatory requirements and timelines.
• Assist in interactions with regulatory authorities, including coordination with external contractors.
• Ensure effective collaboration with regulatory affairs counterparts to ensure aligned representation and decision making at assigned teams.
• Effectively interact with cross-functional project teams, including external partners, to manage regulatory interactions and submissions to meet project goals.
• Provide regulatory guidance to internal customers including nonclinical, clinical operations, medical affairs, medical writing, biostatistics and program sub teams (Core Teams and Sub-Teams) and external CROs.
• Ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, to meet compliance with appropriate regulations and guidelines.
• Research and analyze applicable regulatory information and provide intelligence information to the team; maintain current regulatory knowledge.
• Other relevant activities as assigned by the Senior Director of European 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.
• Minimum of 5 years regulatory affairs experience in the pharmaceutical or biotechnology industry or government health agency, with a proven track record in managing clinical trial applications and amendments.
• 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.
• Experience in drafting and reviewing regulatory submissions (CTA, MAAs, Variations).
• Excellent interpersonal, communication, analytical, organizational skills, and level of accountability.
• 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.
• Must be able to prioritize and work effectively in an everchanging environment.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• 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.
  
  

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer