Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.
Post : Regulatory Affairs Associate II - CMC US Submissions
Job Description
• Providing regulatory for New Product submission (Pre Approval Activities).
• Review of analytical methods validation protocols and reports of Drug substance and Drug product meeting ICH requirements.
• Timely review of documents (e.g. Master Manufacturing Formula, PDR, Specifications, Stability guidance documents, Comparative dissolution profiles) for Regulatory Dossier submissions.
• Compilation of Dossiers for ANDA/ ANDS submissions.
• Drafting of responses for Deficiency letters or Clarifaxes
• Review of Compiled dossiers
• To maintain and update regulatory database.
Candidate Profile
• B Pharm / M Pharm
• About 5 years’ experience in the profession of Regulatory Affairs
• Knowledge and experience on preparation of dossiers and electronic submission for Health Authorities for North America markets
• Aware of various health authority guidelines like ICH, USFDA, EU
• Hand’s on productivity Applications tools like eCTD, Adobe Acrobat etc.
Additional Information
Qualification : B.Pharm, M.Pharm
Experiences : 5 years
Location : Navi Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th October, 2019
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