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PAREXEL

Senior Regulatory Affairs Associate

PAREXEL
Hyderabad, India
Fresher
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  • Posted 5 hours ago
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Job Description

  • Submitting labelling / safety variations in EU countries including UK and Ireland
  • Preparation and review of M1 documents Cover letter, eAF , Mock-ups, Clinical Overview, Literature References
  • Handled MRP and National procedures in EU
  • Updating the labelling impacted documents - SmPC, PIL and/or Label
  • Artwork update coordination
  • Veeva experience with tracking submissions, updating status, creating HAQ's
  • Excellent communication and CFT coordination.
  • HA correspondence and checking agency websites for approved information

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Pharmaceuticals
Employment Type:
Full time

About Company

PAREXEL

Job ID: 145107003

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Last Updated: 30-03-2026 08:42:14 PM
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