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Regulatory Affairs Specialist

2 weeks ago

Thoothukudi, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 20,00,000

Regulatory Affairs Specialist

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In this role, you will be responsible for preparing and evaluating documents for regulatory submissions. This includes compiling initial dossiers for global markets, developing regulatory strategies, and conducting evaluations of post-approval changes considering global guidelines.

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You will also contribute to lifecycle management activities by reviewing dossier modules, managing submission workflows, and tracking queries using Veeva Vault RIM. Additionally, you will review technical documents from manufacturing sites, including specifications, batch records, and validation data.

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Key Responsibilities:

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  • Prepare and evaluate documents for regulatory submissions.\
  • Compile initial dossiers for global markets, including US, EU, SA, WHO, ANZ, and other countries.\
  • Develop regulatory strategies and conduct evaluations of post-approval changes considering global guidelines.\
  • Manage submission workflows and track queries using Veeva Vault RIM.\
  • Review technical documents from manufacturing sites, including specifications, batch records, and validation data.
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Requirements:

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  • A minimum of 3+ years of experience in managing initial submissions, variations, and full lifecycle management deliverables for global markets.\
  • Proficiency in ICH guidelines and regulatory requirements for US, EU, SA, WHO, ANZ, and other countries.\
  • Hands-on experience in initial dossier compilation, regulatory strategy development, and submission management.