Regulatory Affairs Specialist

4 weeks ago


Chandigarh, Chandigarh, India Parexel Full time

About the Role:

Parexel is seeking a highly skilled Regulatory Affairs Associate to join our team. 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 a strong understanding of 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 a document management system.
  • Coordinate artwork approval processes to meet packaging design and legislation requirements.
  • Monitor and control artwork changes to ensure compliance.

Requirements:

  • 4+ years of experience in drug development, particularly in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
  • Strong understanding of SPL and electronic document management systems.
  • Ability to research and create comparator labeling documents.
  • Excellent communication and collaboration skills.


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