Shilpa Medicare Limited Job Vacancy For Regulatory Affairs/ Regulatory Affairs Executive

Shilpa Medicare Limited Job Vacancy For Regulatory Affairs/ Regulatory Affairs Executive 

Urgent Requirement

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:-

karthik.kumar@vbshilpa.com