Regulatory Publishing Specialist

2 weeks ago


Kollam, Kerala, India beBeePublishing Full time ₹ 80,00,000 - ₹ 1,00,00,000
Job Overview

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

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Key Responsibilities:

  • Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing, ensuring compliance with regulatory guidelines and internal processes.
  • Compile, format, and publish regulatory documents according to global health authority requirements, maintaining attention to detail and organizational skills.
  • Perform quality control of eCTD submissions, including file structure, hyperlinks, and metadata.
  • Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content, tracking submission timelines and deliverables to meet regulatory deadlines.

Required Skills & Qualifications:

  • Strong experience in Veeva Vault eCTD Publishing for BLA submissions, with knowledge of global regulatory requirements.
  • Hands-on experience in preparing eCTD sequences and publishing ready dossiers, with good communication skills to collaborate with multiple stakeholders.
  • Attention to detail, strong organizational skills, and prior experience in Life Sciences / Pharma regulatory publishing are mandatory.

Why this Role is Important:

This role is critical to the success of our regulatory publishing efforts, requiring a skilled professional who can balance complexity and deadlines while maintaining high-quality output.



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