Director, Global Regulatory Affairs
The Director, Global Regulatory Affairs, will be responsible for leading the overall global regulatory strategy and plans for the development and commercialization of assigned vaccine candidates. This role will involve working in a collaborative setting with industry, academia, and government agencies. The successful candidate will report to, and work closely with, the Vice President, Global Regulatory Affairs and Pharmacovigilance.
- Provide the Regulatory leadership and guidance required for the global development of vaccine candidates through all phases of clinical trials to licensure. Execute the regulatory strategy and plans to achieve development milestones and licensure in all target countries.
- Work with cross-functional product teams to create robust product development plans that include the identification and mitigation of risk.
- Lead the overall planning, drafting and finalization of submissions, from CTAs to MAs.
- Be the primary contact for regulatory authorities for assigned programs. Drive the negotiation of development and submission plans through informal and formal communications, including official meetings.
- Be a driver and contributor to regulatory initiatives to improve strategic capabilities and operational excellence.
- Regulatory expertise in vaccines, both pre- and post-licensure preferred.
- Substantial experience creating, submitting, negotiating, and maintaining CTAs/MAs.
- Comfortable with fast moving development programs where strong collaboration is required with many different internal and external stakeholders.
- Direct experience leading negotiations and meetings with authorities.
- Exceptional oral presentation and written communication skills.
- Demonstrated ability to lead, inspire, collaborate and drive for results.
- Aptitude for identifying risk and working collaboratively on risk mitigation strategies.
- Bachelor Science and advanced degree required.