Parexel – Regulatory affairs Associate Vacancies

Parexel - Regulatory affairs Associate Vacancies
  • Full Time
  • Anywhere
  • ₹350000 - 500000 INR / Month
  • Bangalore
  • Postal Code: 560103
Region: Karnataka

Parexel Hiring Regulatory affairs Associates at Bangalore Location. Interested & Eligible candidates apply now

About the Parexel : Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world.

Regulatory Affairs Associate

  • Relevant years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.
  • To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
  • To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including:
  • Submission delivery strategy
  • Review of documents
  • Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
  • Liaise closely with cross-functional members with aligned product responsibilities.
  • Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
  • Authoring the dossier sections based on the changes to approved MAA
  • Knowledge of change evaluation according to country guidelines
  • Knowledge of CTD guidelines

Education:

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

Apply Here

 

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