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Sunday, March 7, 2010

Drug Regulatory Affairs Executive

Drug Regulatory Affairs Executive
Work location: India Baddi
Job Description :
- Preparation of Registration & Export/ Import dossiers of pharmaceutical formulation for CIS , US & European Countries.
- Liasioning with Government Authorities for regulatory approval
- Co-ordination with R & D, QA/QC for preparation of dossiers.

Qualification : B. Pharm / M. Pharm
Experience : Minimum 2 years in relevant field.

Drug Regulatory Affairs Executive (Institutional)
Work location: India
Job Description :
- Preparation of Registration & Export/ Import dossiers of pharmaceutical formulation for CIS, US & European Countries.
- Liasioning with Government Authorities for regulatory approval.
- Awareness about CTD Formats and CTD Modules details.
- Independently handling of all dossiers as per country requirements.
- Co- ordination with R & D, QA / QC for preparation of dossiers.
- To conduct experimental analysis for the assigned project/s, required to study, develop new formulations / products for Regulated market, and assist in scaling-up and technology transfer.
- Must have experience of Quality Assurance.

Qualification : Science / Pharmacy Graduate
Experience : 2 - 5 years.

ubpl@vsnl.com
hrd@unitedbiotechindia.com

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