Ectd Publishing Specialist

2 weeks ago

Vadodara, Gujarat, India beBeeRegulatoryPublishing Full time ₹ 80,00,000 - ₹ 1,24,00,000
Regulatory Publishing Expertise

We seek a seasoned Regulatory Publishing Specialist to spearhead our team's eCTD submissions in Veeva Vault.

Main Responsibilities:
  • eCTD Submissions: Develop and manage high-quality eCTD submissions in Veeva Vault, adhering to global health authority requirements.
  • Regulatory Document Management: Compile, format, and publish regulatory documents, ensuring compliance with FDA, EMA regulations.
  • Quality Control: Conduct thorough QC of eCTD submissions, including file structure, hyperlinks, and metadata.
  • Cross-Functional Collaboration: Collaborate closely with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.
  • Timeline Management: Track submission timelines and deliverables to meet regulatory deadlines.
Required Skills & Qualifications:
  • Veeva Experience: Strong expertise in Veeva Vault eCTD Publishing for BLA submissions.
  • Regulatory Knowledge: In-depth understanding of global regulatory requirements (FDA, EMA).
  • eCTD Sequencing: Proven experience in preparing eCTD sequences and publishing ready dossiers.
  • Attention to Detail: Meticulous attention to detail with strong organizational skills.
  • Communication: Excellent communication skills to collaborate effectively with multiple stakeholders.
  • LIFE SCIENCES EXPERIENCE: Prior experience in Life Sciences / Pharma regulatory publishing is essential.

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