Regulatory Publishing Expert for eCTD Submissions

2 days ago


Amrāvati, Maharashtra, India beBeePublishing Full time ₹ 90,00,000 - ₹ 1,22,50,000

Key Responsibilities:

  • We are seeking a highly skilled Regulatory Publishing Specialist to prepare and manage BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
  • The ideal candidate will compile, format, and publish regulatory documents according to global health authority requirements.
  • Strong attention to detail and excellent organizational skills are necessary to ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
  • A collaborative mindset is required to work with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.
  • The successful candidate will be responsible for tracking submission timelines and deliverables to meet regulatory deadlines.

Required Skills & Qualifications:

  • Proven experience in Veeva Vault eCTD Publishing for BLA submissions.
  • Knowledge of global regulatory requirements (FDA, EMA).


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