eCTD Publishing Specialist

2 weeks ago

Thāne, Maharashtra, India beBeePharmaregulator Full time ₹ 1,20,00,000 - ₹ 2,50,00,000

As a Regulatory Publishing Specialist, you will play a crucial role in ensuring the successful preparation and submission of Biologics License Applications (BLA) in eCTD format.

Key Responsibilities:
  • Submission Preparation: Compile, format, and publish regulatory documents according to global health authority requirements.
  • Compliance: Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
  • 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.

Required Skills & Qualifications:

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

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