Teva Regulatory Affairs Associate Job Opening – Pharma
Teva Regulatory Affairs Associate Pharma Job. Teva hiring Pharmacy candidates for the post Specialist.Teva Hiring Undergraduate Pharmaceutical Science candidates. Teva is a global pharmaceutical leader and the world’s largest generic medicines producer committed to improving health. Check out all the details on the same below:
Job Title: Regulatory Affairs Associate II – CMC US Submissions
Location: Navi Mumbai, IN, 400706
Eligibility: B Pharma, M Pharma
Experience: 5 years
Role Description Summary:
- Providing regulatory for New Product submission (Pre Approval Activities).
- Description of KEY responsibilities (describe the main results of the job to be achieved):
- Ensure the requirements for submission of ANDAs & EU MA applications.
- Review and compile documents for New submissions & DLs responses and ensure the high quality content/document for product submissions in line with USFDA/ HC requirements
Skills and specific knowledge required
- 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.
- 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
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