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 Po