Global Regulatory Strategist

• Develop global or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives.
• Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities.
• Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions.
• Writing regulatory documents (e.g. new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed.
• Provide strategic direction (and content input) on US Labelling.
• Anticipate and interpret key trends and changes in the global/US 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 Commercial, Medical Affairs, 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 GRS.

Education & Experience:

• Ph.D., M.D., PharmD., MS or commensurate experience.
• Significant experience in regulatory affairs (e.g., 3-5 years).
• Expert understanding of policy, laws, regulations, and guidelines as they apply to U.S.
• FDA for drug development and approval.
• Expert understanding of drug development process and understanding of scientific content and complexities related to a project in Oncology.
• Direct experience in developing strategy and leading teams through interactions with FDA.
• Extensive experience in initiating and conducting successful interactions within FDA.
• Strong ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals.
• Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals.
• Communicates opinions, facts and thoughts with clarity, transparency, and honesty.
• Demonstrates ownership of results within (and beyond) area of responsibility.
• Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
• Looks for opportunities for continuous improvement.