Virchow Biotech Pvt Ltd-Hyderabad is hiring Executive
Virchow Biotech Pvt Ltd-Hyderabad is hiring Executive
Vacancy Details:
Manager or Sr manager for Regulatory Affairs with below mentioned
job description.
1)Following up with the CDSCO(DcGI), CDSCO(Zonal office), State FDA(DCA), NPPA, CBN and all govt authorities for the processing of applications of Biologic and Blood Products.
2) Preparation and reviewing application for Manufacturing and Marketing of New Drug and Subsequent New Drug (CDSCO Form CT-21)
3) Preparation and reviewing application for Import and Marketing of New Drug (CDScO Form CT-18)
4) Preparation and Presenting Firm Proposal to SEC Committee to substantiate Firm Application to
CDSCO.
5) Preparing and reviewing application for New Drug Product Manufacturing Permission and Approved Drug Product Manufacturing Permissions (CDSCo
Form CT-10 and Form 29).
6) Preparing and reviewing application for Test License for New Drugs and Approved Drug in India (CDSCO Form CT-16 and Form 12)
7) Preparing and reviewing application for BE-NOC (CDSCO Form CT-05 and Form CT-16).
8)Preparing and reviewing application for Import NOC and Export NOC.
9)Preparing and reviewing application for import permission for APls for commercial purposes (Form 40).
10)Submissions of all applicable applications online via Sugam Portal. Prepare and submit the query responses as and when required online.
11)Liasoning with NCB for Submission of Quarterly Returns
12)Liasoning with CBN for Import NOC applicationand quarterly Returns.
12) Submissions of BE-NOC amendments,Notifications and EC approved Protocols to CDSCOoffice.
13)Involved in co-ordination with Plant, R&D andQA-QC Department for review, preparation andcollection of documents.
14)Tracking of Projects by excel sheets, coordinatingwith Project managers for timely delivery of Projects.
15) Frequent teleconference with various team forsmooth progress of Projects.
16)Prepare, review and maintain an archival ofapplications, approvals received from CDSCO.
17)Maintaining relations with Regulatory Officials i.e.Drug Inspector, Assistant Drug Controllers etc. of various departments to resolve the issues related toany kind of permission, NOCs, & Licenses; preparing, reviewing, submitting technical and other documents/dossiers with Drug Controller General of India/CDSCO/State FDAs for-Registration for import of Pharmaceuticals Formulations and Bulk Drugs and Preparing and reviewing ANDAs for USFDAsubmission.
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