Regulatory Publishing Professional

5 days ago

Kanpur, Uttar Pradesh, India beBeePublishing Full time ₹ 15,00,000 - ₹ 20,00,000

Job Overview

We are seeking a highly skilled Regulatory Publishing Specialist to join our team. As a key member of our organization, you will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing, adhering to global health authority requirements.

Main Responsibilities:

  • BLA Submission Management: Prepare and manage BLA submissions in eCTD format, ensuring accuracy and attention to detail.
  • Regulatory Compliance: Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes, maintaining accuracy and attention to detail.
  • eCTD Submission Quality Control: Perform QC of eCTD submissions, including file structure, hyperlinks, and metadata, to guarantee submission readiness.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content, track submission timelines, and deliverables to meet regulatory deadlines.

Key Skills and Qualifications:

  • Veeva Vault Expertise: Strong experience in Veeva Vault eCTD Publishing for BLA submissions, including eCTD sequences and publishing ready dossiers.
  • Global Regulatory Knowledge: In-depth knowledge of global regulatory requirements (FDA, EMA), ensuring compliance and accuracy in document preparation.
  • Attention to Detail: Attention to detail with strong organizational skills, maintaining high-quality standards in document management.
  • Communication Skills: Good communication skills to collaborate with multiple stakeholders, facilitating seamless team collaboration.

Prior Experience Required: Prior experience in Life Sciences / Pharma regulatory publishing is mandatory for this role.

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