Virchow Biotech Require Regulatory Affairs Manager
VBPL is an ISO 13485:2012 and WHO – GMP certified leading global player in Biopharma sector having more than 15 years of operational experience, situated at Hyderabad. We also have offices located in USA. Innovative, ever motivated Research team and uncompromising manufacturing team in providing quality products are our strengths.
Post : Executive Manager or Sr manager for Regulatory Affairs
1) Following up with the CDSCO(DCGI), CDSCO(Zonal office), State FDA(DCA), NPPA, CBN and all govt. authorities for the processing of applications.
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 APIs 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) Submissions of BE-NOC amendments, Notifications and EC approved Protocols to CDSCO office.
13) Involved in co-ordination with Plant, R&D and QA-QC Department for review, preparation and collection of documents.
14) Tracking of Projects by excel sheets, coordinating with Project managers for timely delivery of Projects.
15) Frequent teleconference with various team for smooth progress of Projects.
16) Prepare, review and maintain an archival of applications, 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 to any 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 USFDA submission.
18) Liasoning with CBN for Import NOC application and quarterly Returns.
Location : Hyderabad
Candidates can share their updated resume on email@example.com
Last date : 20 Nov 2022
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