Regulatory Affairs Strategist for Oncology Product Development

3 days ago

South Plainfield, New Jersey, United States Katalyst Healthcares and Life Sciences Full time
Job Title: Regulatory Affairs Strategist for Oncology Product Development

**Overview:**
Katalyst Healthcares and Life Sciences is seeking a highly experienced Regulatory Affairs Strategist to join our team. As a key member of our Global Regulatory Strategy group, you will be responsible for developing and executing regulatory strategies for Oncology products in development and through life cycle management.

**Estimated Salary:** $120,000 - $180,000 per year

**Key Responsibilities:**
  • Develop global or US regulatory strategy for Oncology products in development, 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.
  • Write regulatory documents (e.g. new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); review core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed.
  • Provide strategic direction 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.


**Requirements:**
  • 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.

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