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Regulatory Affairs Associate
at Rangam
Thousand Oaks, CA

Regulatory Affairs Associate
at Rangam
Thousand Oaks, CA

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Description

The Regulatory Affairs Associate (CMC) provides varying levels of product support to the Chemistry, Manufacturing and Controls (CMC) function, which is responsible for Module 3 of regulatory submissions across phases of product development from clinical to lifecycle.

  • Support may include organizing, managing and executing on regulatory CMC projects in support of regulatory submissions
  • Tasks may include formatting of documents per style guide, searching for and organizing data from regulatory repository systems, drafting meeting agendas and minutes, managing document reviews, and other tasks as requested
Qualifications
  • Master's degree and 2 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience OR Bachelor's degree and 4 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience OR Associate's degree and 6 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience OR High school diploma / GED and 8 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical, and/or related scientific experience
  • Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project
  • Strong organizational skills with attention to detail
  • Proficient time management skills and ability prioritize workload
  • Project management skills
  • Adept interpersonal and communication skills (both verbal and written)
  • Ability to work both independently and as a member of a team
  • Experience in biopharmaceutical or pharmaceutical industry
  • Familiarity with eCTD structure
  • Motivated with initiative to learn quickly
  • Experience in CMC, including preparation of submissions to Agencies

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