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Senior Regulatory Affairs Associate

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Parexel

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Location:
India

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

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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:

  • Assess change controls, author and prepare submission documentation, respond to Health Authority queries
  • Review published outputs of regulatory packages, management of data submissions to authorities (XEVMPD, PMS, etc.) as requested

Requirements:

  • High level of expertise in the lifecycle management of radiopharmaceutical products, including CMC authoring, safety labelling experience, artworks annotations
  • Assess change controls, author and prepare submission documentation, respond to Health Authority queries
  • Review published outputs of regulatory packages, management of data submissions to authorities (XEVMPD, PMS, etc.) as requested
  • Effective communication and collaboration skills, and the ability to work independently.
What we offer:
  • Flexible work arrangements
  • Opportunities for career growth
  • Supportive and inclusive environment
  • Diverse and global client exposure
  • Learn from experts

Additional Information:

Job Posted:
May 17, 2026

Work Type:
Remote work
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