Regulatory Affairs Director

This client is a clinical stage biotechnology company developing gene therapies for the treatment of rare neurodegenerative disorders.  They are seeking a Director of Regulatory Affairs to lead strategies and activities for their pipeline programs and manage upcoming US and EU submissions.  You will interact directly with regulatory agencies and collaborate internally with cross-functional teams.   This is an exciting time to join the field of gene therapy and to become a part of this fast growing company which is passionate about improving patients’ lives.

Responsibilities:

  • Develop US and EU regulatory strategies for the development of gene therapy products for rare diseases.
  • Oversee and manage preparation and submissions including INDs, CTAs, BLAs, and MAAs.
  • Collaborate with the nonclinical, clinical and CMC teams to ensure seamless integration of components in all submissions
  • Participate in interactions and negotiations with regulatory agencies to clarify and solidify strategy and resolve issues
  • Lead preparation of agency meetings and actively participate in scheduled meetings
  • Drive adherence to regulatory requirements and guidelines
  • Perform regulatory intelligence activities including changes in regulations and competitor trends.

 

Knowledge and Skills:

  • Bachelor’s degree in a scientific field. MS/PhD preferred but not required.
  • At least six or more years of regulatory pharmaceutical product development experience.
  • Regulatory affairs experience with biologic programs is required. Experience with gene therapy a plus.
  • Knowledgeable in ICH, FDA, EMA and WHO regulations/guidelines.
  • Prior experience managing regulatory submissions in the US and EU.
  • Strong experience with cross-functional interactions, excellent project management and writing skills, and a good understanding of the underlying science.
  • Ability to work independently and thrive in a fast paced environment.
  • Strong attention to detail and well organized and able to multi-task.
  • Outstanding communication and time management skills.
  • Must have confidence, initiative, and a good sense of humor!

 

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