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Biological E
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Regulatory Affairs - Asst. Mgr/Sr. Exe/Exe | Vaccine/Biotech Industry

Regulatory Affairs - Asst. Mgr/Sr. Exe/Exe | Vaccine/Biotech Industry

Biological E

3 - 8 years

5 - 11 Lacs

Hyderabad

Posted:3 months ago| Platform:

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Skills Required

Regulatory Affairs Biologics NRA ROW Countries CDSCO CTD Dossier Preparation Sugam Vaccine Injectables Regulatory Compliance WHO

Work Mode

Work from Office

Job Type

Full Time

Job Description

Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Main purpose of the Job: Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities. Job Responsibilities: 1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to. a. Application for Post Approval Change(s) b. Marketing Authorization Applications c. Clinical trial applications d. Support the submission of Import licenses/ export NoC e. Support the preparation, review and submission of applications/ response to RCGM vide IBSC f. Support in handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites 2. Assisting in Responding Queries to various regulatory authorities. 3. Preparation of dossiers / submission packages for NRA submissions. 4. Preparation of dossiers for registration in ROW countries. 5. Maintenance of Documentation Data base available with RA. 6. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing. 7. Routine Interaction with QA-documentation for updating Master Files. 8. Review of Pack Profiles. 9. Review of Artworks (Labels and Package Insert). 10. Preparation / compilation of technical documents related to tenders / queries. 11. Arranging Samples required for registration. 12. Any other support required by the other members of RA. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for Department Name

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Regulatory Affairs - Asst. Mgr/Sr. Exe/Exe | Vaccine/Biotech Industry