Sr. VP/Regulatory Affair

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Location
MA
Job Type
Direct Hire
Date
Jun 26, 2018
Job ID
2607485
Sr. VP, Regulatory Affairs   
 
 
The Sr. Vice President of Regulatory Affairs will be responsible for all aspects of Regulatory Affairs related to clinical development, CMC and commercialization. This person will be responsible for leading the strategic direction and operational aspects of global regulatory compliance and submissions for all projects across the company.
 
  • Create and implement a regulatory strategy and related activities for approvals
  • Develop and implement strategies for submissions and approval of regulatory submissions from IND through BLA
  • Ensure regulatory compliance of marketed and investigational drugs with the FDA and other applicable regulatory jurisdictions (e.g. EMA)
  • Manage the submission and maintenance of INDs, BLA’s etc.
  • Actively participate on project teams providing regulatory strategy, guidance and compliance oversight 
  • Identify and assess regulatory risks for assigned projects or programs
  • Must have a background in biologics
  •  
Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
  • Solid knowledge and understanding of regulatory policies and guidance
  • Demonstrated leadership ability as well as ability to be a team player and work well within cross-functional teams 
  • Strong ability to work in a global setting 
  • Excellent operational skills
Please contact Joellen Lane; FPC of Cambridge; (978) 535-9923; joellen@fpccambridge.com for more information.