A Public Limited Company in the Business of Manufacturing & Marketing of APIs and Drug Intermediates with an Annual Turnover of about Rs.70 Crores with a significant presence in the international market.
Post: Regulatory Affairs (Formulation) Executive
Job Description:
To collate and compile dossier as per CTD requirement and any related submissions as per filing plan of solid oral dosage form (tablets/capsules) for regulated market
Handling and responding to all product specific queries
Candidate Profile:
Having atleast 2-3 years work experience in Regulatory Affairs for regulated market like EU, US, Canada, Australia and South Africa markets.
Having knowledge about ICH guidelines, EMA, USFDA, TPD, TGA & MCC guidelines.
Additional Information:
Experience: 2-3 Years
Location: Hyderabad
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA, F&D
End Date: 5th Oct., 2011
Forward Your CV at, careers@glochemindia.com
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