CMC Regulatory Affairs Associate

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• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Authoring 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.
• A wide degree of creativity and latitude is expected.
  

Responsibilities

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Authoring 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.
• A 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.
• Able 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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Legal

• Industries

  Pharmaceutical Manufacturing

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