Assistant Manager - Submission Publishing in Bombay, भारत
Abbott
Bombay, भारत
Abbott seeks an experienced regulatory affairs professional to manage submission publishing and product registration processes. This role involves directing regulatory submissions, liaising with agencies, and advising internal teams on compliance matters throughout the product lifecycle.
Responsibilities
Direct development of product registration submissions, supplements, amendments, and periodic reports
Interact with regulatory agencies to facilitate approval of pending registrations
Serve as regulatory liaison across product lifecycle and internal teams
Advise development and marketing teams on manufacturing changes and technical labeling
Ensure timely approval and compliance of new and marketed products
Requirements
Associate's degree or equivalent qualification
Minimum 1 year regulatory affairs experience
Subject matter expertise in regulatory submissions and registration processes
Strong communication skills for cross-functional stakeholder engagement
Knowledge of CMC, risk management, and regulatory strategy
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