Regulatory Affairs Specialist
TeamPlus
Years of Experience: 2 years
Must have good knowledge of Regulatory documents Preparation.
Must have good knowledge of Regulatory Research.
Must be familiarity with chemical industry specific regulations and guidelines.
Technical Expertise: Proven experience in preparing USDMF, CEP, ASMF, Customer DMF from Scratch and maintaining ASMFs/DMFs and CEPs (initial submissions and variations). Able to prepare Open part and closed part of API/Excipient.
Regulatory Compliance: Ensure company products comply with relevant regulatory requirements, such as USFDA, EMA, and local regulations.
