Shilpa Medicare Ltd (SML) deals in high-quality Active Pharmaceutical Ingredients (APIs), Bulk drug, Intermediates, Formulations and Development service, New Drug Delivery Systems, Peptides / Biotech products and Specialty Chemicals etc. using sophisticated technology meticulously in order to comply with laid down international standards/specifications. SML is among the world’s leading suppliers of Oncology/Non-Oncology APIs and intermediates.
Regulatory Affairs Requirement for Shilpa Medicare Limited.
1)Regulatory Affairs Associate – US ANDA – Injections
- Exp : 5-8 yrs.
- Location :Nacharam, Hyderabad.
Job description:
- US Regulatory Affairs. Submission of ANDAs.
- Drafting/ Compilation/ Publishing of dossiers for US Submissions.
- Response to information request/ Deficiencies from US FDA in timely manner.
- Injectable Dosage Forms & Complex Generics
- Post approval Supplements, Annual Reports.
If anyone interested, Pl share your updated resume to karthik.kumar@vbshilpa.com
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2)Regulatory Affairs Executive
- Exp : 2-5 yrs.
- Location :Nacharam ,Hyderabad.
Job description:
- Regulatory Submissions to India (CDSCO/ DCGi).
- 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.
- Compilation of submission documents and upload on to the portals (TDLS/ Sugam Portal).
- Analysis of deficiencies from authority and provide response on time.
- Archival & maintenance of product approvals & licences.
- Liaising with regional authorities for the licences.
If anyone interested, Pl share your updated resume to karthik.kumar@vbshilpa.com
References are highly appreciated.
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