Publishing Specialist

1 day ago

Kanpur, Uttar Pradesh, India beBeeRegulatory Full time ₹ 12,00,000 - ₹ 15,00,000

Job Opportunity:

Regulatory Publishing Role

We are seeking a highly skilled Regulatory Publishing Specialist to join our team in the preparation and management of BLA submissions in eCTD format using Veeva Vault eCTD Publishing.

  • The ideal candidate will have strong experience in preparing and managing regulatory documents according to global health authority requirements, ensuring compliance with regulatory guidelines and internal processes.
  • A key responsibility will be to compile, format, and publish regulatory documents, as well as perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.
  • Collaboration with cross-functional teams to gather and manage content is essential, along with tracking submission timelines and deliverables to meet regulatory deadlines.

Required Skills & Qualifications:

Technical Expertise
  • Strong experience in Veeva Vault eCTD Publishing for BLA submissions is mandatory.
  • Knowledge of global regulatory requirements and hands-on experience in preparing eCTD sequences and publishing ready dossiers are also required.
  • In addition, the ideal candidate should possess attention to detail, strong organizational skills, and good communication skills to collaborate with multiple stakeholders.
  • Prior experience in Life Sciences/Pharma regulatory publishing is highly valued.

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