Mankind Pharma Released Job Openings On 22/11/2022. Mankind Pharma is an Indian pharmaceutical company, based at New Delhi, India. The company has products in therapeutic areas ranging from antibiotics, to gastrointestinal, cardiovascular, dermal, and erectile dysfunction medications.
Mankind Pharma Recruiting M.pharma Graduates with 02-05+ Years of Experience for Regulatory Affairs position.
Important Details :
- No of Vacancies:NA
- Details of Salary: NA
- Opening date for online Application: 22/11/2022
- Mode of application :Online
- How To Apply: Interested candidates can mail their updated CVs to email@example.com
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Job Description/Skills Required
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