Location
Columbia, Maryland
Job Type
Full-time
Posted
May 16, 2026
Job Description
Top Skills:
Responsibilities:
- 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
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...
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