Regulatory Affairs Director

6 days ago

Manchester, New Hampshire, United States Travere Therapeutics Full time
Job Title: Executive Director, Regulatory Affairs

At Travere Therapeutics, we are seeking a highly skilled and experienced Executive Director, Regulatory Affairs to join our team. This role will be responsible for developing and executing global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease.

Key Responsibilities:

  • Develop and execute fast to market regulatory strategies, regulatory requirements for clinical studies, marketing approval, evidence generation, and life cycle management.
  • Manage interface with outside regulatory agencies and trade associations and act as an advisor/liaison to senior management in order to plan, evaluate, and recommend global regulatory strategy.
  • Accountable for the preparation, submission, and maintenance for product-specific dossiers (IND/CTA, NDA/MAA, and others as required) per local country requirements with relevant health authorities.
  • Negotiate with regulatory authorities and respond to regulatory authority queries during the development and review process to ensure submission approval.
  • Ensure annual licenses, registrations, listings, and patent information are maintained.
  • Ensure compliance with product post-marketing approval requirements.
  • Ensure labeling, publications, advertising, and promotional items are compliant with regulatory requirements.
  • Assess regulatory impacts associated with changes made in the development of products.
  • Collaborate with internal stakeholders (Medical, Clinical, preclinical) and project leadership team to define or develop and obtain registration documents as required to support global development actions.
  • Provide leadership with global regulatory strategy teams to ensure development of team members through the sharing of knowledge and expertise on strategic thinking and regulatory precedence reviews.
  • Ensure regulatory tools are complaint and kept up to current standards.
  • Participate in product development and acquisition assessment teams to evaluate potential Regulatory Strategies.
  • Formulate department procedures, as required.
  • Recruit, develop, manage an effective regulatory team, and elevate the leadership capabilities both via direct and indirect reporting structure to foster and create a goal-oriented culture.
  • Build partnership with senior key stakeholders from other functions to ensure strategic business goals are met through the sharing of knowledge and expertise.
  • Back-up activities of Vice President as required.

Requirements:

  • Bachelor's degree in a scientific discipline. Master's degree preferred. Equivalent combination of education and applicable job experience may be considered.
  • 12+ years of increasing Regulatory Affairs experience and responsibility, including proven success with product registrations, rare disease development highly desirable.
  • 6+ years of supervisory/management experience in biotech or Pharmaceutical industry.
  • Demonstrated track record of successful approvals from a major regulatory agency is required. Prior regulatory agency liaison experience is essential.
  • Demonstrated experience in both Regulatory Strategy development as well as associated Regulatory tactical and operational activities.
  • Experience with portfolio management and program prioritization.
  • Advertising and promotional labeling experience is required.
  • Excellent written and communication and interpersonal skills and proven success working in a multi-functional team-based environment.
  • Strong expertise and knowledge of the drug development process is required. Experience in biologics, drug safety, pharmacovigilance, and/or risk management preferred.

Additional Skills/Experience/Requirements:

  • Strong ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.
  • Strong influencing and negotiation skills.
  • Ability to function effectively in a global scientific and cultural arena.
  • Demonstrate leadership capacity managing multiple projects and complex timelines in a highly matrixed team environment by interacting effectively with internal departments and external organizations.
  • Excellent team management skills, ability to lead, manage complexity/change, time-sensitive project plans, budgets, train, and coach/mentor team members at all levels.
  • Works independently under general supervision. Exercises judgment within generally defined practices and policies.
  • Ability to travel 15-20% domestic 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: $235,000.00 - $315,000.00

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