Electronic Document Specialist

2 weeks ago

Thoothukudi, Tamil Nadu, India beBeePublishing Full time ₹ 8,00,000 - ₹ 16,00,000
Regulatory Publishing Specialist Role

We are seeking a highly skilled Regulatory Publishing Specialist to join our team.

  • The ideal candidate will have strong experience in Veeva Vault eCTD Publishing for BLA submissions and knowledge of global regulatory requirements (FDA, EMA).
  • They will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing, compiling, formatting, and publishing regulatory documents according to global health authority requirements.
  • The successful candidate will also ensure compliance with regulatory guidelines (FDA, EMA) and internal processes, perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.
  • Collaboration with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content, track submission timelines and deliverables to meet regulatory deadlines.

About the Job:

  • Main 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 QC 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.

Key Qualifications:

  • Experience in Veeva Vault eCTD Publishing for BLA submissions.
  • Knowledge of global regulatory requirements (FDA, EMA).
  • Strong organizational and time management skills.
  • Excellent communication and collaboration skills.

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