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PAREXEL

Senior Regulatory Affairs Associate

PAREXEL
Hyderabad, India
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Job Description

  • High level of expertise in the lifecycle management of radiopharmaceutical products, including CMC authoring, safety labelling experience, artworks annotations
  • Assess change controls, author and prepare submission documentation, respond to Health Authority queries
  • Review published outputs of regulatory packages, management of data submissions to authorities (XEVMPD, PMS, etc.) as requested
  • Effective communication and collaboration skills, and the ability to work independently.

More Info

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

About Company

PAREXEL

Job ID: 148317257

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Last Updated: 25-05-2026 10:03:26 PM
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Senior Regulatory Affairs Associate-- Radiopharmaceuticals

PAREXEL
Hyderabad, India

Skills:

PMS, XEVMPD, CMC authoring, change controls, data submissions, submission documentation, regulatory packages, safety labelling, lifecycle management of radiopharmaceutical products