Regulatory Affairs Director

4 weeks ago

Tarrytown, New York, United States Regeneron Pharmaceuticals Full time
Job Summary

This is an exciting opportunity to lead the work of a team advancing Regeneron's pipeline in general medicine within the Regulatory Strategy group in Regulatory Affairs.

The incumbent will lead a group of highly motivated individuals working to develop approaches to study candidate therapeutics in general medicine with a focus on cardiovascular and metabolic diseases, including weight loss and muscle preservation products.

Experience with the successful advancement of products in cardiovascular and metabolic diseases is preferred.

A strong interest in the science and biology of disease and disease prevention, along with robust skills in the communication of scientific information, are essential.

This is an opportunity to work in a highly dynamic, science-driven organization to advance the development of therapies to meet the needs of patients around the globe.

The position provides an opportunity not only to lead a team and work with a cross-functional team supporting product development but also to interact with senior managers in the company on regulatory strategies for product development.

Key Responsibilities

  • Responsible for regulatory strategies for development programs in the assigned therapeutic area to ensure Regulatory Agency approval within specified timelines of all activities in support of Regeneron's corporate development and marketing objectives.
  • Manages liaisons and/or provides direction to regulatory representatives to project teams who effect and communicate regulatory strategies.
  • Review critical regulatory communications. Evaluate conformance with the regulatory requirements, clarity, and completeness.
  • Responsible for ensuring necessary state of compliance for all regulatory commitments/requirements.
  • Supervises/manages others to ensure that all reporting requirements and other commitments are met with respect to INDs, BLAs, CTA, etc.
  • Supports liaisons with their project-specific communications, including Agency meetings.
  • Responsible for the completeness and accuracy of information provided in regulatory submissions.
  • Supervises regulatory staff with the planning, preparation, and submission of all regulatory documentation.
  • Responsible for the planning, preparation, and submission of licensing applications.
  • Manages liaisons and/or provides direction to regulatory representatives to project teams who effect and communicate to multidisciplinary teams the content, format, style architecture, and timing of a Biologics Licensing Application (BLA).
  • Review application. Evaluate conformance with the regulatory requirements, clarity, and completeness.
  • Supervise Regulatory staff with respect to commercialization activities associated with new product registrations.
  • Responsible to senior management for timelines/budgets.
  • Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required.

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