Shilpa Medicare Limited - Urgent Requirement for Regulatory Affairs

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Shilpa Medicare Limited - Urgent Requirement for Regulatory Affairs 
1)Regulatory Affairs Associate – US ANDA – Injections

Experience : 5-8 years.
Location :Nacharam, Hyderabad.
Job description:
1. US Regulatory Affairs. Submission of ANDAs.
2. Drafting/ Compilation/ Publishing of dossiers for US Submissions.
3. Response to information request/ Deficiencies from US FDA in timely manner.
4. Injectable Dosage Forms & Complex Generics
5. Post approval Supplements, Annual Reports.
Note: If anyone interested, Pl share your updated resume to karthik.kumar@vbshilpa.com
2) Regulatory Affairs Executive

Experience : 2-5 years.
Location :Nacharam ,Hyderabad.
Job description:
1. Regulatory Submissions to India (CDSCO/ DCGi).
2. Identification of submission requirements to file Subsequent New Drug Applications, CT (CT-04, CT-12, CT-10, CT-16, CT-21 etc) applications, BE NOC, Form 25 & 28 etc.
3. Compilation of submission documents and upload on to the portals (TDLS/ Sugam Portal).
4. Analysis of deficiencies from authority and provide response on time.
5. Archival & maintenance of product approvals & licences.
6. Liaising with regional authorities for the licences.
Note: If anyone interested, Pl share your updated resume to karthik.kumar@vbshilpa.com

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