Teva Regulatory Affairs Associate Job Opening - Pharma

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

Job Description

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.

Job Description

  • 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

Apply Online

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