Regulatory Associate Manager II

4 weeks ago


Bengaluru, Karnataka, India ScaleneWorks Full time

Job Summary

As a Regulatory Associate Manager II at ScaleneWorks, you will be responsible for ensuring the compliance of our business activities with regulatory matters. This includes preparing registration files, briefing books, and clinical trials applications, as well as interacting with colleagues to deliver high-quality dossiers and documents. You will also be responsible for applying system and procedure updates to maintain proper records and supporting adequate controls. Additionally, you will provide evaluations for potential changes and ensure regulatory compliance and completion of internal compliance records. Finally, you will develop up-to-date knowledge of guidelines and regulatory requirements, as well as technical trends.

Key Responsibilities

Prepare registration files, briefing books, and clinical trials applications
Interact with colleagues to deliver high-quality dossiers and documents
Apply system and procedure updates to maintain proper records and support adequate controls
Provide evaluations for potential changes and ensure regulatory compliance and completion of internal compliance records
Develop up-to-date knowledge of guidelines and regulatory requirements, as well as technical trends



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