Pharma Job : Research Associate – Regulatory Associate Post @ Jubilant Life Sciences

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Jubilant Life Sciences Ltd
Jubilant Life Sciences Limited,(erstwhile Jubilant Organosys) is an integrated Pharmaceutical & Life Sciences company. As India’s largest Custom Research and Manufacturing Services (CRAMS) player and a leading Drug Discovery and Development Solutions provider out of India, it is constantly engaged in delivering value to its global customers through innovative technologies, products and services. The Company’s strategic focus is to innovate, collaborate and accelerate the process of delivering products to the market for its customers. Today, it is well recognised as a ‘Partner of Choice’ by leading global pharma and Life Sciences companies. The Company through its presence in India, USA, Canada, Europe and China constantly serves its customers in over 60 countries across the globe.

Job Title  Research Associate – Regulatory Affairs

Experience : 1 – 3 Years

Location : Delhi NCR

Job Description:

Should have worked for US/Canada Mkt

  • Review of IIG and Proportionality of formulations
  • Review of documents and data for the Drug Products specification proposals
  • Review of Product Development Reports
  • Review of Scale Up Reports
  • Review of TTD-2
  • Support For Dossier Submission :
  • Review of Drug Product documents like BMR/BPR/process Validation/Hold-time Reports/Stability Data
  • Support For Dossier Submission :
  • Preparation of dossier document templates
  • Review of Specifications of Raw materials (API and Excipients)
  • Review of Specifications of Raw Finished Products
  • Review of Analytical Validation Protocols and Reports
  • Annual Reports Preparation
  • DMF Review

Qualifications

Education:

UG -B.Pharma – Pharmacy
PG – M.Pharma – Pharmacy

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