Thursday, November 24, 2022

Mankind pharma Hiring for Regulatory Affairs

 WE ARE


HIRING


General Regulatory skills:


Skilled in review of manufacturing/analytical documents, product/packaging development docs, DMF/ technical package for API inputs.


Should have good writing skills and compilation of ANDA /NDA, and good understanding of applicable regulatory guidelines. Good communication & interpersonal skills


Regulatory Affairs


for USA / Other Regulated Markets


⚫ For OSD Regulatory: Hands-on experience in ANDA compilation/submission/lifecycle management of Orals Solids (Tablets, Capsules etc.), including complex products (extended-release, NTI etc.). Familiar with specific requirements and challenges related to regulatory assessment/deficiencies.


EXPERIENCE


2-5 YEARS of relevant regulatory experience


For Sterile products Regulatory: Practical experience in ANDA compilation/submission/lifecycle management of Sterile products (Injectable, Ophthalmic. Inhalation etc.) and complex products (Sterile suspension/ emulsion/peptide etc.) Familiar with specific requirements like Q1/Q2, IID, sterility assurance, extractable/leachable and other typical requirements.


QUALIFICATION


M Pharmacy


⚫ For API Regulatory: Hands-on experience in compilation /submission/lifecycle management of global submissions including US-DMF/CEP etc.


For Device Regulatory: Hands-on experience in 510k compilation/submission/lifecycle management of device submissions.


⚫ For Plant Regulatory: Should be additionally familiar with the change-assessment, data review


Interested candidates can mail their updated CVs to careers.rnd@mankindpharma.com