Shilpa Medicare Limited Job Vacancy For Regulatory Affairs/ Regulatory Affairs Executive
1.Position:-Regulatory Affairs Associate – US ANDA – Injections
Experience: - 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.
2.Position:- Regulatory Affairs Executive
Experience:- 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, Plz share your updated resume on:-
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