CMC Regulatory Affairs Associate

5 days ago

Lake Bluff, IL, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
  • uthoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
  • Review/approval of engineering study protocols/reports and validation study protocols/reports.
  • Review and approval of manufacturing changes for Class III implantable medical devices.
  • May require an advanced degree and 3 to 5 years of direct experience in the field.
  • Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • Performs a variety of tasks.
  • May lead and direct the work of others.
  • wide degree of creativity and latitude is expected.
Requirements:
  • CMC (Chemistry, Manufacturing, Controls) background in completing clinical submissions.
  • IND/IMPD submission background based on manufacturing batch records.
  • Early Phase CMC knowledge a plus.
  • French/ English speaking a plus.
  • Experience Level = 3-5 Years.
  • Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies.
  • Technical writing skills.
  • Familiar with typical manufacturing processes, especially cell cultures.
  • Familiar with microbial methodology.
  • Familiar with ICH and country regulatory procedures for clinical trials.
  • ble to work with electronic systems i.e., Microsoft and dossier publication systems.
  • New manufacturing site in France due to acquiring new business . Contractor needed to complete 3 separate projects for CMC clinical/regulatory submissions. This was a previous commitment for completion from prior company.

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