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Tuesday, January 26, 2010

Alembic Ltd Pharma Regulatory Affairs

Post : Executive/Sr. Executive - Regulatory Affairs
Code : AV-RA
Department : Regulatory Affairs
Qualification : M.Sc.
Location : Vadodara
Posting Date : 9/25/2009
Experience : 3 to 8 years
Profile : Preparation and submission of dossier as per CTD format. Coordination with R&D, QA, QC & production for regulatory requirements for dossier submission and approval. Liaison with clients / local licensees, regulatory authorities. Responsible for preparation of variation and renewal documents.

Alembic Limited
Alembic Road,
Vadodara - 390 003.

+91 - 265 - 228 0550
+91 - 265 - 228 0880
+91 - 265 - 305 3333

ISO-9002 and ISO-14001 certified Asia's most respected integrated pharmaceutical company with manufacturing practices and facilities that conform to WHO-GMP guidelines, Alembic is in the business of improving the quality of life and healthcare in over 75 countries around the world.

We possess capabilities for preparing ANDA in eCTD , Technical Dossiers and Drug Master Files (DMFs) for a range of our products. Our facilities are constantly upgraded to comply with European and US Regulatory inspections, making us strategically poised to enter the regulated markets.Our facilities have been successfully audited by US-FDA and European Agencies. We have filed and received approval of some of our ANDAs and COS from respective Regulatory agencies.



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