Regulatory Affairs Associate at Katalyst CRO

• Job Location Columbia, MD
• Seniority Associate
• Type Contract

Description

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

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.

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.

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).