Executive – Import & Export-

Years of Experience: 2 years

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.

Submission Management: Prepare and submit regulatory documents to regulatory agencies.
Regulatory Strategy: Develop and implement regulatory strategies to support product development and commercialization