Regulatory Publishing Specialist – eCTD Submission Expert

21 hours ago

Belgaum, Karnataka, India beBeePublishing Full time ₹ 75,00,000 - ₹ 1,25,00,000

Job Title:

Regulatory Publishing Professional

As a key member of our team, you will play a crucial role in preparing and managing regulatory submissions in eCTD format. You will be responsible for compiling, formatting, and publishing regulatory documents according to global health authority requirements.

This is an exciting opportunity to work on high-profile projects and contribute to the success of our organization. If you have a strong background in regulatory publishing and excellent organizational skills, we encourage you to apply.

About the Role:

  1. Prepare and manage regulatory submissions: Utilize Veeva Vault eCTD Publishing to compile, format, and publish regulatory documents.
  2. Collaborate with cross-functional teams: Work closely with Regulatory, Clinical, and CMC teams to gather and manage content.
  3. Ensure compliance and quality control: Verify adherence to regulatory guidelines (FDA, EMA) and internal processes.
  4. Track submission timelines and deliverables: Meet regulatory deadlines by tracking submission timelines and deliverables.

Requirements:

  • Veeva Experience: Strong experience in Veeva Vault eCTD Publishing for regulatory submissions.
  • Regulatory Knowledge: Knowledge of global regulatory requirements (FDA, EMA).
  • eCTD Sequencing: Hands-on experience in preparing eCTD sequences and publishing ready dossiers.
  • Attention to Detail: Excellent attention to detail with strong organizational skills.
  • Communication: Good communication skills to collaborate with multiple stakeholders.
  • Life Sciences Experience: Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.

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