Director/Sr. Director Regulatory Strategy

Our client is a commercial-stage biopharmaceutical company focused on the discovery and development of targeted therapeutics for the treatment of rare neuromuscular diseases. They are seeking a Director or Sr. Director of Regulatory Strategy to formulate and lead implementation of regulatory strategies for their new gene therapy programs which will be starting first-in-human trials next year.  This is a high profile position where you can make a big impact on the company and also on patients’ lives.

Responsibilities:

  • Develop regulatory strategies that provide a streamlined development and approval timeline for pre-clinical gene therapy programs
  • Guide project teams to implement appropriate regulatory strategies.
  • Represent the company at FDA and EMA agencies for all assigned products. Oversee the planning and conduct of meetings with regulatory agencies as appropriate.
  • Plan and manage integration of multidisciplinary regulatory programs into the project team development plans for all assigned projects.
  • Initiate and respond to regulatory agency contacts to assure expedient and efficient review and approval of products.
  • Accurately interpret regulatory guidelines and advise senior management on any proposed regulatory, scientific, and pertinent legal issues.
  • Ensure that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well-organized, accurate, high quality and are in regulatory compliance.
  • Supervise and coordinate all regulatory activities required for submissions to regulatory agencies for assigned products.

 

Knowledge and Skills:

  • Bachelor’s degree in a scientific field. MS/PhD preferred but not required.
  • 10+ years of regulatory affairs experience within the biopharmaceutical industry with development experience.
  • Regulatory affairs experience with biologic programs is required. Experience with gene therapy a plus.
  • Knowledgeable in ICH, FDA, and EMA regulations/guidelines required
  • Demonstrated knowledge of drug development process is essential.
  • Must have prior experience working with the FDA and EMA.
  • Experience working on a successful NDA and/or BLA.
  • Strong communication and interpersonal skills.

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