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Senior Assistant, Regulatory Affairs

Senior Assistant, Regulatory Affairs sought by ChemWerth in Woodbridge, CT. Prep, submit APDM files and regualtion submissions to FDA and agencies; DMF maintenance; Prep DMF deficiency responses with ANDA sponsors and API suppliers; Product tech packages; Monitor API supplier changes; Ensure proper comparability; Develop regulatory strategy, gain agency approval; etc. Equal opportunity employer. 


recblid js44pn1tsta15m58xkpz6r9quizwq2

Posted
12/19/2021
Type
Full time
Location
Bridgeport, CT 06604, US