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BriefCase

Regulatory Affairs Associate Ii Job in Teva Pharmaceutical Industries Ltd.

Regulatory Affairs Associate Ii

Teva Pharmaceutical Industries Ltd. 4+ weeks ago
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Job Summary Company InfoTeva 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. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!Job Description
  • Review of analytical methods validation protocols and reports of Drug substance and Drug product meeting ICH requirements.
  • Review of documents, Stability guidance documents for Regulatory Dossier submissions
  • Review of Comparative dissolution profiles
  • Assessment IIG, elemental Iron content, elemental Impurity assessment reports, residual solvents assessment reports etc. confirming the regulatory requirements for approval of new formulations strategies.
  • Specifications review and approvals. (API, Excipients, In-process, Finished Product, Stability etc.)
  • Review and approval of Change control forms.
  • Review and comments of API vendor documents e.g. Techpack/ DMF, COAs and specifcations to make sure they are as per Regulatory requirement for our ANDA submission.
  • Review of various study protocols and reports like photostability, split study, in-use stability, multimedia dissolution and alcohol dose dumping as per product requirement.
  • To maintain and update regulatory database for the documents from site, Vendors, etc. required for Regulatory submission.
FunctionRegulatory AffairsQualifications
  • Qual: M Pharm / B Pharm
  • Total years of experience required for the role :6-8 years in New Drug Development Knowledge.
Sub FunctionMedical Regulatory AffairsAlready Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Tevas Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
Experience Required :

Fresher

Vacancy :

2 - 4 Hires

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