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Senior Manager / Associate Director, Regulatory Affairs (Global / Oncology)

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Location
San Francisco, CA
Salary
$1 - $1
Job Type
Direct Hire
Date
Mar 08, 2017
Job ID
2459497
Senior Manager / Associate Director, Regulatory Affairs (Global / Oncology) – San Francisco Bay Area
  • Create content and timelines of regulatory submissions
  • Identify regulatory issues and provide solutions
  • Lead content and publishing of documents for original INDs & NDAs
  • Lead efforts to produce an IND each yea
  • Lead preparations for Regulatory Agency meetings
  • Lead efforts to produce regulatory documents
  • Communicate with global regulatory organizations to prepare applications
  • Assure compliance with regulatory standards and guidance documents
  • Prepare, submit, track, electronic submissions
  • Provide Regulatory guidance to Development and Manufacturing teams
 Requirements:
  • Ph.D, or PharmD
  • 5+ years’ global regulatory experience.
  • Experience with NDA,IND, MAA submissions – Ideal candidate has been part of a successful NDA submission
  • Experience with global regulatory agencies and requirements
  • Strong analytical abilities
  • Oncology experience is high preferred
  • Effective communication skills
  • Collaborative, able to work with cross functional teams
  • Ability to prioritize and manage multiple tasks simultaneously