Regulatory Publishing Specialist

4 days ago


Ajmer, Rajasthan, India beBeePublishing Full time ₹ 15,00,000 - ₹ 25,00,000

Job Summary

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We are seeking a highly skilled Regulatory Publishing Specialist to join our team. In this role, you will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.

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Key Responsibilities:

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  • Submission Preparation: Compile, format, and publish regulatory documents according to global health authority requirements.">
  • Quality Control: Perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.">
  • Collaboration: Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.">
  • Project Management: Track submission timelines and deliverables to meet regulatory deadlines.">
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Required Skills & Qualifications:

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  • Veeva Experience: Strong experience in Veeva Vault eCTD Publishing for BLA submissions is mandatory.">
  • Regulatory Knowledge: Knowledge of global regulatory requirements (FDA, EMA) is essential.">
  • eCTD Sequencing: Hands-on experience in preparing eCTD sequences and publishing ready dossiers is required.">
  • Attention to Detail: Attention to detail with strong organizational skills is necessary.">
  • Communication: Good communication skills to collaborate with multiple stakeholders are essential.">
  • Life Sciences Background: Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.">
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About the Role:

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This is an exciting opportunity for a highly motivated and experienced Regulatory Publishing Specialist to join our team.

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We Offer:

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A competitive salary and benefits package, as well as opportunities for professional growth and development.

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If you are a driven and detail-oriented individual with a passion for regulatory publishing, we encourage you to apply.



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