Department:
107000 Regulatory
Location:
San Diego, USA- Remote
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, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs. This role leads the development and execution of CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management activities for small molecule drug products, with primary emphasis on oral solid dosage forms including tablets and capsules.
The Associate Director serves as the primary CMC Regulatory Affairs representative on cross-functional teams and partners closely with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management to ensure alignment of CMC development plans with regulatory requirements and business objectives.
This position requires extensive experience supporting small molecule drug product development from IND through commercialization, with significant expertise in oral solid dosage forms, drug product manufacturing, formulation development, analytical methods, process validation, and lifecycle management.
The individual will be responsible for driving global CMC regulatory submissions, leading Health Authority interactions related to CMC topics, assessing regulatory risks, and supporting successful product approvals and post-approval activities across major global markets, including the United States (FDA), Europe (EMA), Gulf Cooperation Council (GCC) countries, and Japan (PMDA).
Responsibilities:
CMC Regulatory Strategy, Submissions & Dossier Development
- Develop and implement global CMC regulatory strategies to support clinical development, registration, commercialization, and lifecycle management of small molecule pharmaceutical products.
- Serve as the CMC Regulatory lead on cross-functional program teams, providing strategic regulatory guidance throughout product development and commercialization.
- Partner with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, and Regulatory Operations to ensure CMC activities support regulatory objectives and submission timelines.
- Assess regulatory risks, develop mitigation strategies, and provide strategic regulatory recommendations to support program goals and business priorities.
- Provide regulatory support for products from IND through NDA approval and post-approval lifecycle management, including expedited development pathways where applicable.
- Lead preparation, review, and submission of CMC documentation for global regulatory filings, including INDs, CTAs, IMPDs, NDAs, MAAs, amendments, supplements, variations, annual reports, and responses to Health Authority questions.
- Author and review Module 2 and Module 3 CMC documentation, ensuring technical accuracy, consistency, and compliance with global regulatory requirements.
- Coordinate cross-functional contributions to global CMC regulatory submissions and ensure compliance with regional regulatory expectations.
- Lead CMC regulatory activities supporting initial marketing applications and global registration strategies.
- Serve as the primary CMC representative for Health Authority meetings and responses to regulatory questions.
- Support inspection readiness and regulatory assessments related to manufacturing, quality systems, and product quality.
- Develop filing strategies for post-approval CMC changes, including manufacturing process improvements, formulation changes, specification updates, analytical method changes, manufacturing site transfers, technology transfers, process validation, stability updates, and supplier changes.
Technical Leadership for Small Molecule Drug Products
- Provide strategic regulatory guidance for development and commercialization of small molecule pharmaceutical products, with primary emphasis on oral solid dosage forms including tablets, capsules, and related modified-release formulations.
- Collaborate with Pharmaceutical Development and Manufacturing teams to support formulation development, process development, scale-up, technology transfer, process validation, and commercial manufacturing.
- Evaluate regulatory impact of manufacturing changes involving active pharmaceutical ingredients (APIs), excipients, formulation development, manufacturing processes, packaging systems, and commercial manufacturing sites.
- Support regulatory strategies for technology transfers, manufacturing site changes, alternate suppliers, and lifecycle management activities.
- Provide regulatory oversight and guidance for analytical method development, validation, specifications, and stability programs supporting product quality and regulatory compliance.
- Contribute to regulatory assessments of critical material attributes (CMAs), critical process parameters (CPPs), critical quality attributes (CQAs), control strategies, and pharmaceutical development throughout product development and commercialization.
- Provide CMC regulatory support for combination products or biologic products when applicable; prior biologics experience is considered advantageous but is not a primary requirement.
Education/Experience Requirements:
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or a related scientific discipline required. Equivalent combination of education and applicable job experience may be considered.
- Advanced degree (MS, PhD, PharmD, or equivalent) in related discipline preferred.
- 8+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry, including significant CMC Regulatory Affairs experience.
- Strong experience with small molecule pharmaceutical products from IND through commercialization and post-approval lifecycle management required.
Additional Skills/Experience:
- The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork
- Driven, intelligent, passionate about making a difference for patients with rare diseases
- Extensive experience supporting oral solid dosage forms, including tablets, capsules, and related drug product manufacturing.
- Demonstrated experience preparing and managing global CMC regulatory submissions, including INDs, CTAs, IMPDs, NDAs, MAAs, amendments, supplements, annual reports, and variations.
- Experience supporting global regulatory activities with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Gulf Cooperation Council (GCC) regulatory authorities, and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
- Experience supporting manufacturing process development, formulation development, process validation, technology transfer, and commercialization of small molecule drug products.
- Experience leading or supporting Health Authority interactions related to CMC topics.
- Demonstrated experience managing post-approval CMC changes, including manufacturing changes, site transfers, specification updates, analytical method changes, supplier changes, and lifecycle management activities.
- Ability to work independently and take ownership of complex CMC regulatory activities.
- Demonstrated leadership capabilities and ability to build effective relationships with internal and external stakeholders.
- Ability to travel 10% domestically and internationally.
- All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.
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:
$150,000.00 – $195,000.00
*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.