Dear All now get GMP News, FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters.. GMPVIOLATIONS

Saturday, February 26, 2011

Sr. Executive / Executive – Regulatory Affairs

Job DescriptionJob profile includes :

• Guidance to R&D, ADL, Manufacturing, Quality for different regulatory requirements, Compilation of DMFs for US, Europe and other Regulatory agencies.

• Review of all technical documents required for the submission of DMFs and ANDAs.

• Preparation and submission of DMFs and ANDAs to regulatory authorities with the time frame.

Desired ProfileCandidate should be M.SC and well versed with ICH guideline, having thorough knowledge regulatory requirements of US, EU and other regulated markets.
Experience3 - 8 Years
Industry TypePharma/ Biotech/Clinical Research
RoleQA/QC Exec.
Functional AreaProduction, Maintenance, Quality
EducationUG - B.Pharma - Pharmacy,B.Sc - Any Specialization
PG - M.Pharma - Pharmacy,M.Sc - Any Specialization
KeywordsRegulatory Affairs RA, regulatory, Pharma, Alembic,
ContactMr Himanshu Jani
Alembic Ltd. 3rd Floor, HRM Division, Corporate
Building, Alembic-Gorwa Road
VADODARA,Gujarat,India 390001


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