Prepares and ensures rapid and timely submission of new drugs and maintain applications to sustain approved status of marketed drug in conjunction with more senior members of the department.
September 24, 2022
Assists with notifying project team colleagues, functional management, and key stakeholders of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
February 06, 2023
Demonstrates basic understanding of regulatory strategy such as broad concepts within regulatory affairs and implications across the organization and globally.
March 18, 2023
Supports project lead (PL) or executes with PL oversight in preparation, submission, and maintenance of regulatory applications, including investigational new drug applications (IND), ex-US clinical trial applications(CTA), routine amendments, annual reports, IND safety reports, etc.
April 02, 2023
Reviews, audits, and compiles documentation for transfers following all compliance protocols to ensure a timely and seamless integration to Acrisure.
April 18, 2023
Maintains and improves working knowledge of current/pending regulations and guidances for generic drugs and new drugs to ensure compliance with FDA requirements.
April 26, 2023