The Sr. Director of Global Regulatory Affairs Strategy is responsible for developing global regulatory strategy for products within scope in development and through life cycle management. Strategies should be based on relevant guidance commercial needs and company objectives.
Develop and lead Global Regulatory strategy for Development team(s) with regulatory team members, creating a global regulatory plan for products in scope, based upon relevant guidance commercial needs and company objectives
Guide team in developing strategic direction for assets/ indications and provide leadership for regulatory interactions.
Anticipate and interpret key trends and changes in the global and US regulatory environment and provide strategic guidance regarding development plan(s)
Foster trust-based relationships with global Health Authorities
Build and maintain strong working relationships with key internal and external stakeholders, including Global Regulatory leadership team, Commercial, Medical Affairs, Advertising & Promotion, Global development and other functions key to the success of product development
Interact routinely and develop strong collaborative relationships with colleagues throughout Global Regularity Affairs, including strategists, CMC, labeling, and Operations
Build and maintain strong working relationships with key external stakeholders, including alliance partners, agencies, and consultants
Provide leadership and strategic direction with regulatory colleagues in development partnership agreements
Oversee or provide due diligence support, as needed
Oversee strategy, preparation and submission of global regulatory submissions
Direct and mentor regulatory staff
PhD, MD or PharmD, or MS with commensurate experience
Understanding of global and US policy, laws, regulatory and guidance/ guidelines
Demonstrated competency in drug development process and understanding of scientific content and complexities. Preferred TAs of interest include gastroenterology, cardiovascular, metabolic and neuroscience.
Direct experience in leading the development of global and US regulatory strategies and leading teams through HA interactions and to drug/ biologics approvals
Experience leading professional regulatory team members
Ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals, including advisory committee meeting(s).
Must be able to work successfully within a team/partnership environment with a high level of professionalism
Global regulatory experience - familiarity with regulations in other countries (e.g., EU, Canada, Australia, Japan) is desired