Senior Specialist, Regulatory Affairs

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 Senior Specialist, Regulatory Affairs (EU/RoW) is responsible for supporting the regulatory leads with program strategies, submissions, operations and 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 assisting in regional regulatory operations, intelligence activities, fulfilling department initiatives, developing and authoring SOPs and will have the opportunity to lead regulatory projects with appropriate oversight.

Responsibilities:

• Supports regulatory leads in the preparation, submission and maintenance of regulatory applications, including clinical trial applications (CTA), routine CTA amendments, pre & post authorization regulatory submissions and annual reports.

• Support regulatory leads in the preparation, review and submission of high-quality responses to questions to regulatory agencies.

• Ensures submissions are complete, properly formatted and comply with applicable regulatory requirements and timelines.

• Assist in interactions with regulatory authorities, including coordination with external contractors.

• Ensures document management and archival systems are maintained.

• May supports Regulatory Operations with regional submissions.

• Coordinates regulatory project activities, tracks commitments, identifies risks and follows actions through to completion.

• Effectively collaborates with regulatory affairs counterparts to ensure submission goals are met.

• Research, interprets and communicates evolving regulatory requirements and emerging regulatory intelligence to support regulatory strategy and submission planning.

• Identifies opportunities to improve regulatory processes, tools and SOPs and contributes to continuous improvement initiatives across Regulatory Affairs.

• Supports various department activities

• 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.

• 4+ years regulatory affairs experience in the pharmaceutical or biotechnology industry or government health agency.

• Good knowledge of the drug development process is required.

• Demonstrated ability to independently assess regulatory issues, evaluate multiple sources of information, exercise sound judgement and develop practical regulatory solutions.

• 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.

• Experience with document management/archival systems (Veeva Vault experience preferred)

• Some flexibility in hours will be required for participating in international teleconferences.

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 skills and excellent verbal and written communication skills are required.

• Ability to travel 10% domestically and internationally.