Regulatory Document Compiler

8 hours ago

Bellary, Karnataka, India beBeePublishing Full time ₹ 15,00,000 - ₹ 20,00,000

Regulatory Publishing Specialist Role

We are seeking a highly skilled Regulatory Publishing Specialist to fill a critical role in our organization. The ideal candidate will have strong experience in eCTD publishing for BLA submissions, as well as knowledge of global regulatory requirements.

Key Responsibilities:

  • Prepare and manage BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
  • Compile, format, and publish regulatory documents according to global health authority requirements.
  • Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
  • Perform quality control of eCTD submissions, including file structure, hyperlinks, and metadata.
  • Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.
  • Track submission timelines and deliverables to meet regulatory deadlines.

Required Skills & Qualifications:

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

This role requires a high level of technical expertise, attention to detail, and excellent communication skills. If you possess the necessary qualifications and are looking for a challenging opportunity, we encourage you to apply.

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