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Regulatory Affairs Associate-Annual Report / Renewals (Biologics)

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Parexel

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Location:
India

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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:

  • To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions
  • Support Annual reports/Renewal experience US/ EU/Brazil/LATAM/China
  • Liaise closely with cross-functional members with aligned product responsibilities
  • Knowledge of change evaluation according to country guidelines
  • Knowledge of CTD guidelines

Requirements:

  • 2 to 4 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts
  • To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions
  • Support Annual reports/Renewal experience US/ EU/Brazil/LATAM/China
  • Liaise closely with cross-functional members with aligned product responsibilities
  • Knowledge of change evaluation according to country guidelines
  • Experience in managing lifecycle activities in the EU markets would be preferrable
  • Knowledge of CTD guidelines

Nice to have:

Experience in managing lifecycle activities in the EU markets would be preferrable

What we offer:
  • Flexibility of working remotely
  • Supportive and inclusive environment
  • Opportunities for career growth
  • Diverse and global client exposure
  • Learn from experts

Additional Information:

Job Posted:
May 17, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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