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Executive Director, Regulatory Affairs
2 months ago
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.
Position Summary:
The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
Responsibilities:
- Key member of the Regulatory and back-up for program Leadership teams.
- Develop, recommend, execute strategic and operational regulatory direction and mentorship on projects including, but not limited to the use of regulatory tools in developing accelerated global regulatory approval strategies using novel endpoints, biomarkers or alternative clinical trial data and critical issue management based on current registration requirements and applicable industry standards.
- 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 (e.g. product submissions, correspondence, meeting requests). Ensure the accurate maintenance of archives and databases as required.
- 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 compliant 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.
Education/Experience 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. 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.
