CMC Regulatory Affairs Associate

Top Skills

• 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

• 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.

• 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