Regulatory Publishing Specialist

4 days ago

Bareilly, Uttar Pradesh, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,50,00,000

Job Opportunity: Regulatory Publishing Specialist

We are seeking a seasoned Regulatory Publishing Specialist to prepare and manage submissions in eCTD format using Veeva Vault eCTD Publishing.

Main Responsibilities:

  • Develop, compile, and publish regulatory documents according to global health authority requirements.
  • Maintain 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 Expertise:

  • Prior experience in Veeva Vault eCTD Publishing for BLA submissions.
  • Familiarity with global regulatory requirements (FDA, EMA).
  • Hands-on expertise in preparing eCTD sequences and publishing ready dossiers.
  • Strong organizational skills with attention to detail.
  • Excellent communication skills to collaborate with multiple stakeholders.
  • Proven experience in Life Sciences / Pharma regulatory publishing is essential.

Bonus Skills:

  1. Knowledge of electronic document management systems.
  2. Aptitude for team collaboration and stakeholder management.
  3. Ability to learn and adapt to new software and processes.

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