Regulatory Affairs Director (Pharma)
Real - Boston, MA

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Keywords:
[REGULATORY AFFAIRS, REG. AFFAIRS, STRATEGY, RA, IND, NDA, ECTD, IMPD, CTA, IND AMENDMENTS, ANNUAL REPORTS, EUROPEAN, FDA, HEALTH AUTHORITY, HEALTH AUTHORITIES,CMC, MODULE 1, MODULE 2, MODULE 3, MODULE 4, PRE-IND, STRATEGY, SUBMISSIONS, COMPLIANCE, MANAGEMENT,ECTD]

Title:
Director of Regulatory Affairs

Role:
This is an exciting role in a growing pharmaceutical company inMassachusetts, to lead regulatory strategy for NCE programs, and assure regulatory compliance with the FDA as well as health authorities. Reporting to the VP of Regulatory Affairs, you will plan, organize, and submit RA submissions in a timely manner, and be responsible for much of the overall strategy. This is an extremely exciting opportunity inNew Jerseyoffering a competitive salary as well as generous benefits. The position has strong focus on domestic strategy, and the right candidate should have experience with regulatory projects in a diverse range of therapeutic areas.

Responsibilities:
  • Provide strategic regulatory support to all functional groups
  • Represent RA on various product 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.
Requirements:
  • Minimum of BS degree in life sciences or related field, ideally an MS or advanced degree
  • At least 12 years of experience in the pharmaceutical industry including 5 plus years regulatory affairs
  • Experience reviewing outgoing FDA correspondences
  • Experience with INDs, NDAs, BLAs, and other regulatory submissions
  • Prior experience interacting with the FDA
  • Knowledge of eCTD publishing software preferred
  • A strong strategic background
Initial phone screenings will be conducted by the end of November and slots are filling up fast!!
To find out more about Real please visit www.realstaffing.com

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