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Regulatory Affairs Associate II (CMC)

Company

Katalyst Healthcares & Life Sciences

Location

Baltimore, Maryland, United States

Posted

May 11, 2026

Position Overview

Responsibilities:

  • Responsible for managing and compiling CMC sections of marketed product variations.

  • Partner with RA CMC Project Leads and develop module 3 content and project timelines.

  • Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.

  • Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.

  • Skills for running review meetings for submission documents.

  • Understand CMC expectations including CTD content, structural and formatting requirements.

  • Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.


Requirements:


  • Bachelor's degree in science 4 years pharmaceutical. 1-2 years cross functional project management...

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