Regulatory Affairs Director

2 weeks ago


Blue Bell, Pennsylvania, United States iECURE, inc. Full time
Job Summary

iECURE, inc. is seeking a highly experienced Director of Regulatory Affairs to join our team. This key role will provide leadership in developing and implementing global regulatory strategies for our innovative gene therapy programs.

The successful candidate will have a strong background in regulatory affairs, with a proven track record of success in developing and executing regulatory plans. They will be responsible for providing strategic regulatory direction, including developing global regulatory plans, advising on regulatory requirements, and managing critical issues and health authority interactions.

  • Develop and implement global regulatory strategies to support product development and commercialization.
  • Provide strategic regulatory direction, including developing global regulatory plans and advising on regulatory requirements.
  • Manage critical issues and health authority interactions, including interactions with the FDA and other global regulatory agencies.
  • Write and review regulatory documents, including INDs, CTAs, and BLAs.
  • Foster positive relationships with global regulatory agencies and stakeholders.

iECURE, inc. is an equal opportunity employer and welcomes applications from qualified candidates.

Requirements
  • MS degree in a life science or related discipline, or equivalent experience.
  • Minimum of 10 years of regulatory affairs experience, with a proven track record of success.
  • Experience working with global regulatory agencies, including the FDA.
  • Strong leadership and communication skills, with the ability to develop and implement regulatory strategies.


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