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Global Regulatory Oncology Lead

4 months ago

Short Hills, United States CYNET SYSTEMS Full time
Job Description:

Pay Range $55hr - $75hr

Responsibilities:
  • Develop global or 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 Labeling.
  • 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:
  • Ph.D., M.D., PharmD., MS or commensurate experience.
Experience:
  • Significant experience in regulatory affairs (e.g., 3-5 years)
Key Competency:
  • Expert understanding of policy, laws, regulations, and guidelines as they apply to 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.
Qualifications:
  • 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.
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