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Regulatory Associate

San Mateo Metro Area, CA

Posted: 04/12/2019 Job Type: Clinical Job Number: JN -042019-24653
One of our biopharmaceutical clients is recruiting for a Regulatory Associate to join their growing team.

Overview:
  • Support day-to-day regulatory activities of assigned projects including preparation and compilation of submissions for regulatory agencies, management of regulatory submissions processes and timelines, and regulatory tracking tools, archives, and infrastructure.
  • Manage document archive processes.
  • Provide support to routine and maintenance submissions.
Education and Experience:
  • Bachelor degree in Life Sciences preferred.
  • Relevant pharmaceutical industry experience including experience in Regulatory Affairs.
  • Knowledgeable of international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
  • Proficient user of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools desirable.
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