Regulatory Affairs Associate I

Job Title: Regulatory Affairs Associate I / Technical Project Manager – Regulatory Affairs CMCJob Description
This role serves as a Technical Project Manager within Regulatory Affairs CMC, focused on supporting marketed product variations and post-approval regulatory changes. You will work at the intersection of Regulatory Affairs, CMC, Manufacturing, Process Development, Analytical Sciences, and other technical functions to develop submission strategies, manage timelines, coordinate cross-functional activities, and ensure the timely delivery of high-quality regulatory submissions. The position is highly collaborative and requires strong project management skills, excellent communication abilities, and a foundational understanding of regulatory submissions, electronic Common Technical Documents (eCTD), and CMC documentation.
Responsibilities

+ Manage regulatory activities related to marketed product variations and post-approval changes, ensuring compliance with applicabl...

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