Electronic Document Specialist

2 days ago

Lucknow, Uttar Pradesh, India beBeePublishing Full time ₹ 8,00,000 - ₹ 16,00,000
Regulatory Publishing Specialist – Veeva eCTD

We are seeking a highly skilled Regulatory Publishing Specialist to join our team. This role will be responsible for preparing and managing Biologics License Application (BLA) submissions in electronic Common Technical Document (eCTD) format using Veeva Vault eCTD Publishing.

Key Responsibilities:
  • Submission Preparation: Prepare and manage BLA submissions in eCTD format, ensuring compliance with global health authority requirements.
  • Document Compilation: Compile, format, and publish regulatory documents according to global health authority guidelines.
  • Quality Control: Perform quality control of eCTD submissions, including file structure, hyperlinks, and metadata.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams to gather and manage content.
  • Timeline Management: Track submission timelines and deliverables to meet regulatory deadlines.
Required Skills & Qualifications:
  • Veeva Experience: Strong experience in Veeva Vault eCTD Publishing for BLA submissions is essential.
  • Regulatory Knowledge: Knowledge of global regulatory requirements, including those from FDA and EMA, is necessary.
  • 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 crucial.
  • Communication Skills: Good communication skills to collaborate with multiple stakeholders are necessary.
  • Lifesciences Experience: Prior experience in Life Sciences or Pharma regulatory publishing is mandatory.

Why Choose Us? As a Regulatory Publishing Specialist, you will have the opportunity to work on high-profile projects, develop your skills, and contribute to the success of our team.

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