Senior Manager Regulatory Affairs Strategy
Real - Maryland

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Senior Manager Regulatory Strategy

I have an urgent need for an experienced regulatory affairs professional who can provide regulatory strategies and liaise with key global regulatory authorities. You Will be responsible for both Domestic and International regulatory strategy, and should be able to manage and negotiate efficient product development plans. If you are looking for an opportunity to grow your global regulatory role understanding and utilize your experience in pre-clinical through the Phase III regulatory development.

  • Respond to queries from FDA associated with NDA submissions
  • Take lead roles in pre-IND meetings and FDA conference calls
  • Independently review and provide feedback to the promotional review committee related to promotional marketing items.
  • Take lead Role in NDA submission strategy
  • Provide regulatory guidance to global product development and regulatory teams.
  • Create, organize and manage the preparation of all types of FDA submissions
  • Coordinate, compile and submit regulatory applications
  • Organize and maintain reporting schedules for regulatory applications
  • Lead associates and train them to review and prepare basic regulatory documents.Evaluates changes to regulatory documents and formulates strategies to maintain submission goals.
  • Minimum of BS degree in life sciences or related field, ideally an MS or advanced degree
  • At least 10 years of experience in the pharmaceutical industry including 7 years regulatory affairs
  • Experience reviewing outgoing FDA correspondences
  • Experience with INDs, NDAs, CTAs, BLAs, and other regulatory submissions
  • Prior experience interacting with the FDA
  • Knowledge of eCTD publishing software preferred
  • A strong strategic background
If you are looking for the challenge and reward of working on the development of innovative products where you are actively leading and contributing to regulatory strategy, then make sure to apply
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Real - 22 months ago - save job
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