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Our performance-oriented culture and dynamic business approach attract top talents in many areas, including R&D, marketing and sales, finance and administration. This helps us run a team full of young minds as well as industry veterans who work constantly towards improving the lives of millions.

Position: Clinical Research Associate – Bioequivalence Studies

Location: Mumbai, Maharastra

Job Description:

  • Reviewing BE study protocols received from CRO and ensuring its completeness with respect to scientific and regulatory requirements.
  • Reviewing in vitro dissolution data received from R & D in line with the available guidance.
  • Reviewing the draft and final BE study report and ensuring its correctness as per applicable regulatory requirements.
  • Maintaining BE study-related documents for respective studies.
  • Perform monitoring visits at CRO to verify source documents.
  • Monitor the progress of the study and ensure the timelines as per the agreed task order.
  • Finalizing study-specific task order with the selected CROs.
  • Co-ordinate with the CROs for the proper execution of BE studies.

  • Responsible for handling regulatory queries.
  • Responsible for overall conduct and management of BE activities.
  • Co-ordinating for an import license and BE NOC with the regulatory team.

Qualification: M.Pharma

Experience: 1-5 Years of Relevant Experience

Salary: Negotiable

Age Limit: 25-30 Years

Contact Details:

hrd.mumbai@ipca.com / hrdtech.mumbai@ipca.com

OR     Click here to Apply Now

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