Associate Director of Regulatory Affairs

Practice Area bioscience
Job Family Regulatory Affairs
Job Type Perm Salary
Location Greater Boston
Do you have a flexible mindset and the ability to multitask? Do you demonstrate leadership, problem-solving, flexibility and teamwork skills? If so, this Associate Director of Regulatory Affairs position is for you! To learn more, submit your resume and apply today.

Responsibilities:
  • Oversee all aspects of regulatory support and strategy on the designated product(s).
  • Employ a comprehensive understanding of global regulations and guidelines for oncology projects to enhance probability of regulatory success and compliance.
  • Independently defines content (data and documentation) requirements for regulatory submissions and reviews this content with established requirements.
  • Lead the preparation of regulatory submissions including INDs, CTAs, annual reports, and, briefing packages.
  • Ensure the project team objectives and timelines are supported by regulatory deliverables.
  • Maintain a working knowledge of all pertinent laws, regulations and guidance relevant to oncology and the specific product areas.
  • Provide expertise in the interpretation of regulations and guidance relating to product development.

Requirements:
  • BS/BA Degree in a Scientific Discipline
  • 8+ years pharmaceutical Regulatory experience.
  • Broad understanding of drug development and oncology
  • Competency in FDA regulatory requirements is essential. Global experience is a plus
  • Excellent verbal and written skills
  • Exercises good judgement in elevating and communicating actual or potential issues to line management.

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Position ID: 38663