Regulatory Affairs Specialist

2 weeks ago


Bengaluru, Karnataka, India Parexel Full time

Parexel is seeking a highly skilled Senior Regulatory Affairs Associate- Labeling to join our team. In this role, you will play a critical part in ensuring compliance with key labeling regulations and guidelines.

About the Role:

  • We are looking for an individual with 4+ years of experience in drug development, specifically in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
  • You should have a 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 is essential.
  • A strong understanding and experience creating annual reports is also required.
  • You must be able 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 is necessary.
  • Familiarity with electronic document management systems and/or electronic submission experience is an advantage.
  • Lifelong learning and enthusiasm for staying up-to-date with industry developments and emerging trends are desirable.
  • Maintaining accurate records and adhering to strict deadlines while handling multiple tasks simultaneously is important.

What We Offer:

  • This is an excellent opportunity to work on a challenging project that requires your expertise.
  • The salary for this position is estimated to be between $80,000 and $120,000 per year, based on location and experience.
  • Additionally, we offer a comprehensive benefits package, including health insurance, retirement plans, and paid time off.

How to Apply:

Please submit your application, including your resume and cover letter, through our website. We look forward to hearing from you



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