Our Generics Regulatory Affairs team in Weston, FL is currently seeking a Regulatory Affairs Associate II to join their team. The Regulatory Associate II will be responsible for preparing regulatory submissions in accordance to FDA guidelines.
The Regulatory Affairs Associate II, with minimal guidance, prepares, reviews and submits high quality, regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include ANDAs, amendments, supplements, annual reports and additional documents as needed. -Compiles and reviews ANDAs, amendments, supplements, annual reports, control documents, etc., for FDA submissions. -Interacts effectively with functional business units in order to coordinate facilitate documentation required for submissions, ensuring that departmental timelines are met.
Preparing ANDAs and amendments for FDA submission.
Evaluating change controls and provide the regulatory assessment.
Performing special projects assigned by Regulatory Affairs management.
Other duties, as assigned, or as business needs require.
Timely submissions and expeditious approvals.
Maintains compliance with regulatory requirements for generic drugs for the US market.