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Regulatory Affairs Specialist

1 month 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 labeling and compliance team, you will be responsible for ensuring that all regulatory requirements are met for our products.

Job Summary:

  • 4+ years of experience in drug development, particularly in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
  • Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging).
  • The ability to research and create comparator labeling documents.
  • Strong understanding and experience creating annual reports.
  • The ability to collaborate with Tech Ops for artwork implementation.
  • Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
  • Electronic document management systems use and/or electronic submission experience.
  • Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.
  • Must have handled CCDS related submission/safety variations/PSUR/xEVMPD/label and artwork updates.
  • Coordinate artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging.
  • Monitor, manage and control artwork changes.
  • Manage and maintain Artwork Trackers & Systems.
  • E nsure artwork PDFs are maintained and latest versions are readily available.
  • Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved

What We Offer:

  • A competitive salary range: $120,000 - $150,000 per annum, depending on qualifications and experience.
  • A dynamic and supportive work environment.
  • Ongoing training and professional development opportunities.
  • A comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.

About Parexel:

Parexel is a leading global biopharmaceutical services company that provides end-to-end solutions to help clients accelerate the discovery, development, and delivery of innovative medicines and medical treatments. Our team at Parexel is passionate about making a difference in people's lives through the development of life-changing therapies.