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MANAGER - REGULATORY AFFAIRS


Source:
TIMESJOBS.COM
Date:
17-11-2016
Job Code:
58309930
Categories:
  • Biotechnology & Science
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Job Details

Responsible for coordination with various departments for the collation & review of various regulatory documents for adequacy Responsible for the preparation & review of briefing packages, CTD write-up and query response documents. Responsible for coordination & communication with national & international regulatory agencies, agents & business partners for various regulatory requirements. Responsible for review of various documents for regulatory impact assessment & coordination of regulatory compliances. Responsible for review & compilation of dossier for the national & international regulatory bodies as per the prescribed current regulatory guidelines. Responsible for the coordination & filling of post approval changes & annual regulatory updates. Good understanding of National & International regulatory requirements for Biosimilars. Good understanding of GMP & Quality System.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science)

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 8-13

Requirements

Clinical Research | Regulatory Affairs
Applying for this job will take you to an external site

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