Executive Director, Regulatory Affairs
4 weeks ago
We are seeking a highly experienced and skilled Executive Director, Regulatory Affairs to join our team at Travere Therapeutics. This is a key leadership role that 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.
- Bachelor's degree in a scientific discipline. Master's degree preferred.
- 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 environments.
- Strong expertise and knowledge of the drug development process is required.
- Experience in biologics, drug safety, pharmacovigilance and/or risk management preferred.
- 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.
- Considered to be a key opinion leader and resource both within Travere and externally.
- 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.
- Ensures effective liaison with regulatory affairs counterparts to ensure aligned representation and decision making at assigned teams.
- Ability to travel 15-20% domestic and internationally.
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.
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 *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.
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