Reviews advertising and promotional pieces for accuracy and for other legal/regulatory requirements and communicates planned/approved changes with other functions, including but not limited to medical affairs and commercial teams.
February 17, 2023
Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
November 09, 2022
Develops or participates in the development of Regulatory solutions to problems involving several concrete variables in, or from, standardized situations of moderate to low complexity that may affect a narrow functional area.
December 26, 2022
Prepare documentation meeting regulatory requirements, identifying and using existing documentation where possible, or managing creation of new documentation, working directly when needed with Subject Matter Experts in outside departments (R&D, Manufacturing, Quality, etc.
March 21, 2023
Supports the compilation of Agency submissions for regulatory pathways including but not limited to clinical development (excluding single study clinical trial applications), marketing authorizations, product variations and renewals of international medicinal products.
April 24, 2023
Participate in the study management and collaborate with regulatory operations as it relates to all regulatory submissions.
May 13, 2023