Mankind Pharma Hiring for Regulatory Affairs Department; M Pharmacy candidates

  • Full Time
  • USA

Mankind Pharma

Mankind WE ARE HIRING for  Regulatory Affairs for USA / Other Regulated Markets

EXPERIENCE: 2-5 YEARS of relevant regulatory experience

QUALIFICATION: M Pharmacy

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

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.

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.

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

Mankind Pharma Hiring for Regulatory Affairs Department; M Pharmacy candidates
Mankind Pharma Hiring for Regulatory Affairs Department; M Pharmacy candidates

To apply for this job email your details to careers.rnd@mankindpharma.com

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