Shilpa Medicare Limited - Urgent Requirement for Regulatory Affairs

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