Mankind Pharma, the 7th largest Pharmaceutical Company of India, was incepted in 1995 with a meagre capital of 50 lakhs and 20 employees. Today, we are amongst the top 5 fastest growing Pharmaceutical companies of India with an employee base of more than 10000 and heading towards a turnover of INR 3000 crores.
Post : Regulatory Affairs
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, NT1 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 firstname.lastname@example.org
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