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:
Travere is seeking a Vice President, Regulatory Strategy Diligence to lead the Regulatory Due Diligence team including Regulatory Strategy assessments of clinical/commercial-stage assets associated with external business development opportunities. This individual will evaluate potential licensing, acquisition, partnership, and external innovation opportunities, identifying material technical risks and practical mitigation strategies across asset development, including endpoint assessment, development path, key milestones, phase appropriate readiness, manufacturing, supply chain, and commercial readiness. The role will closely collaborate with Business Development, Non-clinical, Clinical, Commercial, Legal, Regulatory, Technical Operations and Quality leaders to support transaction decisions and post-deal integration planning.
The successful candidate will ensure Regulatory considerations for Nonclinical, Clinical and Reg CMC are fully integrated into the overall business development strategy and help Travere distinguish material risks from manageable issues to make informed investment and partnership decisions. The ideal candidate brings deep Regulatory development expertise across small molecules, biologics (including gene therapy), ATMPs and Companion Diagnostics, shows sound business judgment, is experience in confidential transaction environments, and possesses the ability to effectively translate complex technical findings into clear executive-level recommendations.
Key Responsibilities:
- Lead the Regulatory due diligence for licensing, acquisition, partnership, and external innovation opportunities by assessing readiness risks for clinical/commercial-stage assets.
- Evaluate drug/device regulatory development including all levels of product development, pediatrics, Regulatory strategies, Agency feedback, risks and mitigations along with Timelines and development strategies.
- Own the integrated regulatory risk assessment and recommendation for each opportunity, Identify and champion activities relating to risk and its mitigation distinguishing transaction critical issues; communicate key assumptions, dependencies, potential timeline effects, and proposed mitigation.
- Evaluate CMC drug substance/product manufacturing, product development, control strategies, analytical, validation, stability, technology transfer, and lifecycle management plans.
- Review regulatory aspects of CRO/CMO capabilities, capacity, compliance history, performance, network redundancy, supply continuity, and readiness to support clinical and/or commercial supply.
- Partner with Business Development, Corporate Strategy, Non-clinical, Clinical, Pharmacovigilance, Quality, Regulatory, Finance, Legal, Program Management, and Technical Operations stakeholders.
- Prepare timely, concise diligence reports, risk registers, executive presentations, and post-transaction recommendations.
- Lead regulatory, documentation and technical input into term sheets, definitive agreements, quality agreements, supply agreements, transition plans and joint collaboration governances.
- Establish enterprise regulatory diligence strategy, standards, tools, templates and risk frameworks.
- Advise leadership on regulatory considerations for strategic transactions.
- Additional duties assigned as needed.
Education/Experience Requirements:
- Master’s or PhD (preferred) in pharmaceutical sciences, biological sciences, engineering, chemistry, chemical engineering, or related scientific discipline required. Equivalent combination of education and applicable job experience may be considered.
- 15+ years of relevant experience in pharmaceutical or biotechnology industries with experience with regulatory and pharmaceutical development with a Business Development focus including clinical, manufacturing and technical operations, process, or related functions required; preferred experience with progressing late-stage assets from clinical development through commercialization.
- 8 years of previous people management and leadership experience.
- Experience in similar strategic management position with significant experience interacting with executive leadership required.
- Professional experience in similar role within biotech/pharmaceutical industry, preferably supporting both biologics and small molecule development and commercialization.
- Strong understanding of GMP requirements, regulatory expectations and guidance, clinical trial design, statistical and process validation, analytical development, technology transfer, and product lifecycle management.
- Demonstrated experience leading or contributing to due diligence, asset evaluations, licensing, acquisitions, partnerships, or external alliance assessments.
- Ability to synthesize and articulate and communicate complex regulatory and technical information into clear risks, recommendations, timelines, and mitigation plans to both internal and external audiences, including senior management.
- Excellent communication and influencing skills; rare disease, orphan drug development, global supply, regulatory submission, or post-deal integration experience preferred.
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.
- Skilled with building strong partnerships across internal functions and with external partners, consultants, CROs, CDMOs, and SMEs.
- Contribute to continuous improvement of diligence tools, templates, risk frameworks, and evaluation standards.
- Operate effectively in a fast-paced, confidential, and matrixed environment with shifting priorities and compressed timelines.
- Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills.
- Excellent decision-making and collaboration skills with strong attention to detail.
- 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.
- Ability to travel 10-20% domestically and internationally.
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:
$285,000.00 - $385,000.00
*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.
