Director, US Regulatory Strategy CV/Met(Job Number: 1300410)
- Develop the U.S. regulatory strategy for CV/Metabolic products in development and through life cycle management taking into account all relevant guidance, commercial needs and company objectives.
- Develop strategic direction and provide leadership for all regulatory interactions with FDA. Anticipate and interpret key trends and changes in the U.S. regulatory environment and provide strategic guidance regarding development plans as a result. Foster positive relationships with FDA.
- Build and maintain a strong, collaborative relationship with all key stakeholders including U.S. Commercial, U.S. Medical Affairs, U.S. Promotion & Compliance, Global Development and other functions key to the success of product development.
- Interact routinely and will develop a strong team environment with colleagues throughout Global Regulatory Sciences, including Global Regulatory Team leaders and other key functions within Global Regulatory Sciences.
Job Function: Regulatory
- Ph.D., M.D., PharmD. Understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA for drug development and approval.
- Understanding of drug development process and understanding of scientific content and complexities related to a project.
- Direct experience in developing strategy and leading teams through interactions with FDA.
- Experience in initiating and conducting successful interactions within FDA.
- Ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals.
Primary Location: NA-US-NJ-Princeton
: R&D - Global Regulatory Sciences & Pharmacovigilance (GRS&P)
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