Regulatory Affairs Specialist

3 weeks ago


Mohali, Punjab, India Parexel Full time

About the Role:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with labeling regulations and guidelines.

Key Responsibilities:

  • Develop and maintain expertise in key labeling regulations and guidelines, including CCDS and USPI.
  • Collaborate with cross-functional teams to ensure accurate and compliant labeling.
  • Manage the review and approval of labeling documents in document management systems.
  • Coordinate artwork approval processes and manage artwork trackers and systems.
  • Ensure compliance with regulatory requirements for labeling and artwork.

Requirements:

  • 4+ years of experience in drug development, particularly in labeling, product package coordination, and clinical supplies/packaging.
  • Strong understanding of labeling regulations and guidelines.
  • Excellent communication and collaboration skills.


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