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Wednesday, November 21, 2012

Executive - Regulatory Affairs

Job Description
  • Basic Knowledge of Clinical research and Indian regulatory procedures
  • Basic understanding of clinical trial activities 
  • Preparation and review of required regulatory documents and / information for submission to regulatory authorities for Clinical trials and Bioavailability and Bioequivalence studies as per departmental SOPs. 
  • Coordinating with the interfacing departments for procuring appropriate information for submission to regulatory authorities 
  • Coordination with regulatory liaison persons to ensure timely submissions. 
  • Archival of approvals, licenses, study dossiers appropriately in the regulatory affairs department. 
  • Submission of subsequent protocol amendments, clinical trial reports, annual status reports and any study related information to the regulatory authorities. 
  • Registration of clinical trials with Clinical Trial Registry India (CTRI) wherever applicable. 
  • Good communication and interpersonal skills.
Desired ProfilePlease refer to the Job description above
Experience1 - 3 Years
Industry TypePharma, Biotechnology, Clinical Research
RoleRegulatory Affairs Manager
Functional AreaMedical, Healthcare, R&D, Pharmaceuticals, Biotechnology
EducationUG - B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy, M.Sc - Any Specialization
KeywordsClinical Researchregulatory affair
Micro Labs Limited
# 27 Race Course Road KCN Towers Bangalore - 1
BANGALORE,Karnataka,India 560001

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