BRAWN, with its inception barely 21 years back(1988) has today evolved into a fully integrated, healthcare group, marking its presence in India and dotting various major markets across the globe. With its claim of quality and certified with ISO 9001:2000, 13485, WHO : cGMP, BRAWN is proud to possess product registration with major health and govt. institutions throughout India and in many other countries worldwide.
Headed and represented by a team of skilled industry experts with impressive educational backgrounds and broad experience, BRAWN continues to spread its wings in expansion in the domestic as well as in the international markets with a vision beyond the existing horizon to stand among the leading Indian HealthCare Companies.
Post: Regulatory Affairs Manager
Job Description:
1. Preparation and submission of Dossiers for registration in European countries in CTD format & for ROW market(ASIAN,CIS,LATIN AMERICAN etc)in ACTD and asa per their guidlines.
2. Coordination with R&D, QA, QC & production for regulatory requirements.
Candidate profile:
Prepare & Reviewed documents like BMR, BPR, STP, Specifications, labeling review (artwork), PIL comparison, F&D, Process Validation Protocol. Communication with the country agent related to dossier compilation.
Additional Information:
Experience: 3-5 Years
Location: Delhi
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
End Date: 9th July, 2011
Email your resume to, hrd@brawnlabs.com
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