Demonstrates basic understanding of regulatory strategy such as broad concepts within regulatory affairs and implications across the organization and globally.
September 26, 2021
Maintains and improves working knowledge of current/pending regulations and guidances for generic drugs and new drugs to ensure compliance with FDA requirements.
October 12, 2021
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.
October 16, 2021
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.
November 22, 2021
Reviews, audits, and compiles documentation for transfers following all compliance protocols to ensure a timely and seamless integration to Acrisure.
November 24, 2021
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.
December 15, 2021