Chief Regulatory Affairs Officer

1 week ago

San Diego, California, United States Travere Therapeutics Full time
Director of Global Regulatory Affairs

Department: Regulatory

Location: San Diego

Join a dedicated team committed to improving the lives of individuals affected by rare diseases.

At Travere Therapeutics, we value our outstanding employees as the cornerstone of our achievements. Our team is passionately focused on addressing the distinct needs of patients with rare conditions. The work we do is fulfilling on both a professional and personal level, as we strive to make a meaningful impact. We are enthusiastic about our mission.

Position Overview:

The Director of Global Regulatory Affairs will spearhead the formulation and implementation of global regulatory strategies and tactical plans for the advancement of innovative therapies for rare diseases, ensuring expedited global product approvals, ongoing product compliance, and adherence to local regulations.

Key Responsibilities:

  • Act as a pivotal member of the Regulatory and program Leadership teams.
  • Formulate, advocate, and implement strategic and operational regulatory guidance for projects, including the utilization of regulatory instruments to develop accelerated global approval pathways utilizing novel endpoints, biomarkers, or alternative clinical trial data.
  • Design and execute strategies for rapid market entry, regulatory requirements for clinical trials, marketing approvals, evidence generation, and lifecycle management.
  • Oversee interactions with external regulatory bodies and industry associations, serving as an advisor to senior management on global regulatory strategies.
  • Accountable for the preparation, submission, and maintenance of product-specific documentation (IND/CTA, NDA/MAA, etc.) in accordance with local health authority requirements.
  • Negotiate with regulatory agencies and address inquiries during the review process to secure submission approvals.
  • Ensure compliance with post-marketing approval obligations.
  • Maintain compliance of labeling, publications, advertising, and promotional materials with regulatory standards.
  • Evaluate regulatory implications associated with product development changes.
  • Collaborate with internal teams (Medical, Clinical, preclinical) to define and develop registration documents necessary for global development initiatives.
  • Lead global regulatory strategy teams to foster the development of team members through knowledge sharing and expertise in strategic thinking and regulatory precedents.
  • Ensure regulatory tools are compliant and updated to current standards.
  • Participate in product development and acquisition assessment teams to evaluate potential regulatory strategies.
  • Establish departmental procedures as necessary.
  • Recruit, mentor, and manage a high-performing regulatory team, enhancing leadership capabilities to cultivate a goal-oriented culture.
  • Build partnerships with senior stakeholders across functions to ensure alignment with strategic business objectives.
  • Support the Vice President as needed.

Education and Experience Requirements:

  • Bachelor's degree in a scientific field; Master's degree preferred. Equivalent combinations of education and relevant experience may be considered.
  • 12+ years of progressive experience in Regulatory Affairs, with a focus on product registrations and rare disease development.
  • 6+ years of management experience in the biotech or pharmaceutical sectors.
  • Proven track record of successful approvals from major regulatory agencies is essential.
  • Experience in both Regulatory Strategy development and associated tactical and operational activities.
  • Familiarity with portfolio management and program prioritization.
  • Experience in advertising and promotional labeling is required.
  • Exceptional written and verbal communication skills, with a history of successful collaboration in multi-functional team environments.
  • Strong understanding of the drug development process is necessary, with preferred experience in biologics, drug safety, pharmacovigilance, and risk management.

Additional Skills and Experience:

  • Ability to apply scientific principles to evaluate regulatory challenges, gather relevant information, analyze data, and draw valid conclusions.
  • Strong negotiation and influencing skills.
  • Capacity to operate effectively in a global scientific and cultural context.
  • Demonstrated leadership skills in managing multiple projects and complex timelines within a highly matrixed team environment.
  • Excellent team management capabilities, with the ability to lead, manage change, and mentor team members at all levels.
  • Ability to work independently under general supervision while ensuring effective collaboration with regulatory counterparts.
  • Willingness to travel domestically and internationally as required.

Total Rewards:
Travere offers a comprehensive total rewards package that reflects our commitment to diversity, equity, and a people-centric approach.

Benefits: Our benefits encompass premium health, financial, work-life balance, and well-being offerings for eligible employees and their dependents, along with wellness programs, life insurance, disability coverage, retirement plans with employer matching, and generous paid time off.

Compensation: Our competitive compensation structure includes both cash compensation (base salary and short-term incentives) and long-term incentives (company stock), designed to recognize and reward our employees.

Target Base Pay Range: $235,000 - $315,000.

Travere is committed to providing reasonable accommodations for applicants during the application and interview process.

About Travere Therapeutics

At Travere Therapeutics, we are dedicated to improving the lives of patients with rare diseases. Our biopharmaceutical company collaborates daily to support patients, families, and caregivers from diverse backgrounds as they navigate the challenges of rare diseases. Recognizing the urgent need for treatment options, our global team partners with the rare disease community to identify, develop, and deliver transformative therapies. We continuously strive to understand the diverse perspectives of rare patients and courageously pursue innovative solutions to provide hope for today and tomorrow.

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