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PAREXEL

Senior Regulatory Affairs Associate

PAREXEL
Hyderabad, India
5-7 Years
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  • Posted 9 hours ago
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Early Applicant

Job Description

US & Canada Annual Report

  • Compile list of Annual Reportable or Submitted/Approved CMC Changes.
  • Strategy/Alignment Meetings (either actual meeting or e-mail exchanges).
  • Prepare/Populate CMC Submission Content Plan (SCP) Preparation & Submission.
  • Activities Module 1 authoring Liaise with appropriate functions to collect all required information to submit.
  • Populate the SCP, including e-CTD attributes.
  • Liaise with Regulatory Operations to ensure the publishing order and dispatch of CMC Dossiers.
  • Follow-up with the Country Regulatory Manager (Affiliate) regarding receipt, submission, and acknowledgement by the Health Authority.
  • Store all CMC Dossier and Administrative Documents in the appropriate repository system and close Regulatory Events in RIM.
  • Simple Report includes up to 20 reportable changes and Complex Report includes up to 40 reportable changes.

Ideal Candidate Profile

  • 5+ years of experience in Regulatory Affairs (Pharma).
  • Understanding of US & Canada regulatory requirements for pharmaceuticals.
  • Experience in module 1 authoring.
  • Ability to handle multiple projects and meet submission deadlines.
  • Comfortable working in a fast‑paced, compliance‑driven environment.

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Regulatory Affairs
Employment Type:
Full time

About Company

PAREXEL

Job ID: 147089401

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Last Updated: 08-05-2026 03:24:39 PM
Homejobs in Hyderabad / Secunderabad, TelanganaSenior Regulatory Affairs Associate

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