BSc, MSc Life Sciences Job at Parexel – Online Application Process

Parexel Regulatory Affairs Job Opening For BSc, MSc Life Sciences – Apply Online

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Senior Regulatory Affairs Associate

Location: Bengaluru, India

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Category: Regulatory / Consulting

Senior Regulatory Affairs Associate

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Experience: Biologic CMC

5+ years of experience

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Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to:

  • new application, post approval variations
  • Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation of data to appropriate standards & requirements
  • Experienced in CTD update/authoring ( CTD Module 1, 2&3)
  • Handled and responded Health Authorities Request
  • US & CA Annual reports, Renewals, PQVAR, APR
  • Assessment of the Change Controls and associated technical dossiers
  • Excellent individual project management and communication skills
  • Veeva tool experience

Education:

Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences

APPLY ONLINE

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