Sr Associate Regulatory Affairs

Location: Thousand Oaks, CA
Date Posted: 12-09-2016
Description:
Support Regional Regulatory Affairs, CMC staff; managing product development and lifecycle management activities. Sr. Reg Affairs Associate position will perform activities with the oversight of Sr Manager, to coordinate preparation of CMC documents required for regional regulatory marketing applications, post approval changes, new clinical trial applications and quality amendments. Sr. Reg Affairs Associate will interface with Global Operations and Quality organization, various product development teams, site teams, regional teams, and other contract services as directed.
 
Basic Qualifications
  • Bachelor’s degree and 2 years Regulatory or Regulatory CMC experience OR
  • Associate’s degree and 6 years Regulatory or Regulatory CMC experience OR
  • High school diploma / GED and 8 years Regulatory or Regulatory CMC experience
 Preferred Qualifications
  • Document management system experience
  • Change control management system experience.
  • Common Technical Document format experience.
  • Technical writing and regulatory formatting.
  • Manufacture, testing (QC/QA or clinical), or distribution in Biotech/Pharma industry.
  • Commercialization or marketing application experience.
  • Strong interpersonal skills.
  • Excellent communication (both written and verbal), presentation and facilitation skills.
  • Ability to develop solutions to technical and organizational issues in order to improve performance and productivity.
  • Strong computer skills, including word processing, database and project management software.
  • Strong team player with a commitment to customer service.
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