Mankind Pharma job for Regulatory Affairs job check HQ and apply

  Mankind Serving Life

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

Post

Regulatory Affairs

QUALIFICATION

M Pharmacy

EXPERIENCE

2-5 YEARS of relevant regulatory experience

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.

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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.

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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

Reference - Naitik Patel (Industrial Guide)

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