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Parexel Logo Parexel · Research and Development

Senior Regulatory Affairs Associate

India · Job Posted March 25, 2026
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Job Description

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Job Responsibility

  • Play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape
  • Work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there
  • Partner with a diverse group of clients, and be exposed to various product types and therapeutic areas
  • Develop your skills through challenging assignments and mentorship from experienced regulatory professionals

Requirements

  • Submitting labelling / safety variations in EU countries including UK and Ireland
  • Preparation and review of M1 documents – Cover letter, eAF , Mock-ups, Clinical Overview, Literature References
  • Handled MRP and National procedures in EU
  • Updating the labelling impacted documents - SmPC, PIL and/or Label
  • Artwork update coordination
  • Veeva experience with tracking submissions, updating status, creating HAQ’s
  • Excellent communication and CFT coordination
  • HA correspondence and checking agency websites for approved information

What we offer

  • Flexibility of working remotely
  • Supportive and dynamic team
  • Supportive and inclusive environment
  • Opportunities for career growth
  • Flexible work arrangements
  • Diverse and global client exposure
  • Learn from experts
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