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Associate Director, Regulatory Affairs

  • Job type: Permanent
  • Location: Cambridge
  • Salary: £140000 - £176000 per annum
  • Job reference: JEAO2618625
  • Sector: EPM Scientific, Regulatory
  • Date posted: 06/02/2018
Associate Director, Regulatory Affairs required for Global Bio-pharmaceutical Leader in TGF-beta Science
  • AD, Regulatory Affairs | Biologics Strategy
  • Greater Boston Area
  • $140,000 - $176,000 + excellent bonus + excellent benefits
 
A Global Biopharmaceutical Company, that’s focused on the discovery and development of innovative therapeutics for rare diseases, is actively looking to speak with an experienced RA leader to perform and manage key regulatory activities in compliance with US and Global standards.

The incumbent will portray a strong understand with biologics and leverage that knowledge to provide strategic regulatory guidance associated with product development.

Responsibilities:

  • Act as a primary regulatory representative and provide strategic guidance to project teams
  • Lead the planning and preparation of global regulatory submissions (INDs, CTAs, etc..)
  • Develop and maintain regulatory knowledge of global regulatory standards
  • Maintain active INDs/CTAs
 Qualifications:
  • Minimum 8 years of biotech experience, including 4-5 years in RA
  • Experience in multiple therapeutic areas a plus
  • Orphan drug development experience preferred
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