KH
CMC Regulatory Affairs Associate
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
8 months ago
- Technical Writing
- ICH
8 months ago
Not enough detail in this posting to match
- 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
CMC Regulatory Affairs Associate · Katalyst Healthcares & Life Sciences