Work experience in Pharmacy at Hospitals, Dispensaries, Primary Health Centers in a Ministry / Department / Organization / Public Sector Undertaking / Autonomous Body under Government of India / State Government / UT.
First Class Post Graduate Degree in Life Sciences (Biochemistry/Zoology/Bio technology) including the integrated PG Degrees. or Second Class Post Graduate Degree, including the integrated PG Degrees with PhD.
Strong knowledge of country-specific labeling regulations and guidelines across the US, EU, Canada, Australia, and Switzerland, combined with hands-on experience in label development, including CCDS, USPI, and packaging components.
The Manager, Regulatory Affairs – CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products.
Clearance for visual inspection. Supervision of visual inspection activity. Visual inspection batch record closure. Post line clearance for visual inspection.