Regulatory Publishing Expert

5 days ago

Gandhinagar, Gujarat, India beBeeRegulatory Full time ₹ 40,00,000 - ₹ 75,00,000
Job Opportunity: Regulatory Publishing Expert

Description:

The role of a Regulatory Publishing Specialist involves preparing and managing submissions in eCTD format using Veeva Vault eCTD Publishing. This position requires strong experience in regulatory document preparation, including compilation, formatting, and publishing according to global health authority 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 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.

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.

Why You'll Thrive In This Role:

  • Opportunity to work with cutting-edge technology in Veeva Vault eCTD Publishing.
  • Chance to collaborate with cross-functional teams to drive success.
  • Focus on delivering high-quality regulatory submissions.

What We Offer:

  • A dynamic and supportive work environment.
  • Ongoing training and professional development opportunities.
  • A competitive compensation package.

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