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Senior Regulatory Affairs Associate - Remote

Posted 6 days ago
All others
Full Time
India

Overview

The Senior Regulatory Affairs Associate at Parexel plays a crucial role in handling life cycle maintenance for approved products, ensuring compliance with regulatory requirements across various markets.

In Short

  • Handle Life Cycle Maintenance for approved products.
  • File CMC variations and handle marketing authorization transfers.
  • Review dossiers for EU in eCTD format.
  • Manage Health Authority Queries with precision.
  • Communicate and coordinate with stakeholders for timely submissions.
  • Identify gaps in regulatory processes and suggest improvements.
  • 3 to 8 years of experience in regulatory submissions required.
  • Experience in EU submissions preferred.
  • Hands-on experience with RIMS tools and Veeva Vault is a plus.
  • Work in a collaborative environment committed to improving health.

Requirements

  • 3 to 8 years of experience in regulatory affairs.
  • Experience with EU submissions is preferred.
  • Knowledge of post-approval changes in EU markets.
  • Experience with RIMS tools.
  • Hands-on experience with Veeva Vault tool is a plus.

Benefits

  • Opportunity to make a difference in global health.
  • Work with a team of over 16,000 employees worldwide.
  • Comprehensive drug development capabilities.
  • Support for clients in over 100 countries.
  • Collaborative work environment focused on process excellence.

P.I

Parexel International

Parexel International Limited is a leading global biopharmaceutical services organization headquartered near Boston, Massachusetts, and in Durham, North Carolina. With over 16,000 employees and a presence in more than 100 countries, Parexel specializes in comprehensive drug development capabilities, including regulatory expertise, Phase I-IV clinical research services, and advanced commercialization solutions. The company is dedicated to improving global health by providing innovative clinical development solutions, underpinned by a strong commitment to empathy and making a difference in patients' lives. Parexel's collaborative approach fosters partnerships across various disciplines, ensuring high-quality scientific contributions and the successful delivery of epidemiology services and real-world studies.

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