Job : Executive- Regulatory Affairs, Strides Arcolab Limited, Bangalore
Brought to you by : C-DRIVE   07 16 2010 05:22:04 +0000
Industry : Biotechnology
Role : Executive- Regulatory Affairs
Functional Area : Biopharma
Experience level:  2.0 to 4.0 years
Must Have Skills / Tags :

Regulatory affair

 
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1. Should be able to handle the international Regulatory Affairs for filing of DMs / CTDs to various Regulatory bodies Viz. USDMF, EDMF, CEP with EDQM, TPD-canada

2. Sound knowledge of current regulatory guideline

3. Preparation of DMFs amendments / annual updates/ variation filings

4.Preparing Scientific responses to customer and Regulatory queries

5. Acquaintance with e-CTD filings

1.M.Sc & Diploma in Regulatory Affairs with 2-4 years of experience

2 Excellent communication and interpersonal relations skills

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Strides is one of India’s leading integrated manufacturer and exporter of finished pharmaceutical dosage forms – both branded and generic. They are the significant global player in soft gelatin capsules and sterile parenterals with quality standards that meet the most stringent regulated market......