Regulatory Publishing Professional

4 days ago


Coimbatore, Tamil Nadu, India beBeePublishing Full time ₹ 18,00,000 - ₹ 25,00,000

Job Summary

We are seeking a highly skilled and experienced Regulatory Publishing Specialist to join our team. In this role, you will be responsible for preparing and managing Biologics License Applications (BLA) in Electronic Common Technical Document (eCTD) format using Veeva Vault eCTD Publishing.

Key Responsibilities:

  • eCTD Publishing: Prepare and manage BLA submissions in eCTD format using Veeva Vault eCTD Publishing, ensuring compliance with global health authority requirements.
  • Regulatory Compliance: Maintain compliance with regulatory guidelines and internal processes, performing quality control of eCTD submissions, including file structure, hyperlinks, and metadata.
  • Collaboration: Collaborate with cross-functional teams to gather and manage content, track submission timelines, and deliverables to meet regulatory deadlines.

Required Skills & Qualifications:

  • Veeva Expertise: Expertise in Veeva Vault eCTD Publishing for BLA submissions is essential.
  • Regulatory Knowledge: Familiarity with global regulatory requirements is necessary.
  • eCTD Sequencing: Hands-on experience in preparing eCTD sequences and publishing ready dossiers is required.
  • Attention to Detail: Strong organizational skills and attention to detail are crucial.
  • Communication: Effective communication skills to collaborate with multiple stakeholders are essential.
  • Lifecycle Experience: Prior experience in Life Sciences / Pharma regulatory publishing is preferred.


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