Senior Regulatory Affairs Specialist

Department:

Location:

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 Senior Regulatory Affairs Specialist is a highly motivated, organized and detail-oriented individual who will be responsible for supporting the Regulatory Project Lead on development of regulatory strategy, submissions to FDA and multiple countries (EU, APAC, Latin America) globally, including initial CTAs, INDs, and various amendments and maintenance of regulatory applications. In addition, this position will attend cross-functional team meetings internally and assist in supporting the various CROs. This position will be responsible for assisting in regulatory intelligence activities, fulfilling department initiatives, developing, and authoring SOPs and will have the opportunity to lead regulatory projects with appropriate oversight.

Responsibilities:

• Supports regulatory project lead (PL) or executes with PL oversight in preparation, submission, and maintenance of regulatory applications, including investigational new drug applications (IND), ex-US clinical trial applications (CTA), routine amendments, annual reports, and IND safety reports.
• Attends cross-functional project team meetings.
• Liaises with external vendors in support of regulatory document management.
• Supports project lead during meetings by assisting with scheduling meetings, development of meeting agendas and writing meeting minutes.
• Performs regulatory intelligence research.
• Complies with relevant governing laws, regulations, guidelines and Travere SOPs.
• Assists in the development and authoring of departmental SOPs.
• Supports various departmental initiatives.

Education/Experience Requirements:

• Bachelor's degree in related Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered.
• Minimum 4 years of relevant work experience needed in Biotech or Pharmaceutical industry.

Additional Skills/Experience:

• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Basic working knowledge of US and/or EU regulations and guidance (both regions preferred).
• 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.
• Strong ability to prioritize workload.
• Experience in IND and/or CTA filings a plus.
• Proficient in Microsoft applications; experience with Veeva Vault EDMS and smartsheet a plus.
• Strong professional experience in a similar role within the pharmaceutical industry, in small or large molecule pharmaceuticals.
• Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.

Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.

Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.

Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.

Target Base Pay Range:

*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Travere will accept applications on an ongoing basis until a candidate is selected for the position.

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

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.