Posted:6 hours ago|
Platform:
Work from Office
Full Time
Education : Bachelor/ masters degree in a related field (Pharmacy or Chemistry); Diploma in Regulatory Affairs. Location : Thane Experience: 5-10 years of proven experience in regulatory affairs, specifically with US, EU, UK, and Emerging markets & experience in injectables In-depth knowledge of ICH guidelines, ASEAN CTD requirements, and eCTD publishing. Hands-on experience with regulatory document preparation and review. Strong understanding of QbD principles and ability to analyze trend data. Domain / Functional Key Skills: Keeping up-to-date with changes in regulations and ensuring compliance. Proficiency in preparing, reviewing, and submitting regulatory documents. Ensuring all necessary documentation for product approval is in place, complete, and accurate. Email : monisha.lahiri@randstad.in
Randstad
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