CMC Regulatory Affairs Associate

Company : Katalyst HealthCares & Life Sciences

Location : North Chicago, IL, 60086

Posted Date : 24 October 2025

Job Details

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.