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Director Regulatory Strategy

  • Job type: Permanent
  • Location: Boston
  • Salary: $140000 - $180000 per annum
  • Job reference: MLSN120617143
  • Sector: EPM Scientific, Regulatory
  • Date posted: 06/12/2017
Position Summary:

A leading biopharmaceutical company focuses on high unmet medical needs is looking for a Director, Regulatory Strategy to join a newly opened role.


The Director, Regulatory Affairs will be responsible for developing and implementing regulatory strategy This individual will, with a high sense of urgency, provide operational and strategic regulatory input to cross-functional teams responsible for global programs. 


Principal Responsibilities:
  • Serve as global regulatory team leader on assigned programs.
  • Provides advice on regulatory issues for both marketed and pipeline products; actively collaborates with management and cross functional colleagues within (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
  • Prepares and executes aspects of US regulatory affairs, and ensures integration into global regulatory strategy.
  • Represents as point contact with FDA, including providing support for and coordination of regulatory meetings and information package development.
  • Coordinates submissions to FDA in support of proposed and ongoing development programs, e.g., new IND submissions, IND amendments, etc. 
Qualifications:
  • Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.
  • Experience providing strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds.
  • intra-team relationships and collaborate in a global team environment at all levels of the organization.
  • Strong interpersonal, and written/verbal communication skills.
  • Proven track record practicing sound judgment as it relates to risk assessment
  • Highly conversant and knowledgeable of new and emerging regulations and guidances. 
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