Associate Director - Regulatory Affairs (Contract)

Practice Area bioscience
Job Family Regulatory Affairs
Job Type Contract
Location Greater Boston


Do you have strong communication skills? Do you have exceptional judgement for communicating serious or potential issues upon review? If so, this Associate Director of Regulatory Affairs position is a great fit for you. Submit your resume to apply today!

Responsibilities:

  • Create and implement regulatory CMC development and registration techniques
  • Apply comprehensive knowledge of regulations for antibodies to projects to increase probability of regulatory success and compliance
  • Organize and review modules of development apps, amendments, and additives for submission
  • Make sure annual and periodic reports comply with reporting requirements
  • Identify content requirements for submissions and oversee this content to ensure conformance with established regulations
  • Examine change proposals for filing requirements and regulatory impact
  • Experience with leading International regulatory filings, including electronic submissions, e.g., INDs, CTAs, NDAs, MAAs, annual reports, safety reporting, etc.

Requirements:

  • BS/BA in a scientific discipline
  • Advanced degree preferred
  • 10 or more years of pharmaceutical regulatory CMC experience
  • Leadership and liaison skills when interacting with Regulatory Agencies
  • Ability to guide drug development and registration using scientific principles and regulatory CMC requirements

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Position ID: 38602