Publishing Regulatory Documents Specialist

1 day ago

Delhi, Delhi, India beBeeRegulatory Full time ₹ 1,20,00,000 - ₹ 2,10,00,000
Regulatory Publishing Specialist

We are seeking a highly skilled Regulatory Publishing Specialist to join our team. As a key member of our organization, you will be responsible for preparing and managing submissions in eCTD format using Veeva Vault eCTD Publishing.

Key Responsibilities:

  • Prepare and Manage Submissions: Utilize Veeva Vault eCTD Publishing to create high-quality submissions that meet regulatory standards.
  • Compile and Publish Documents: Format and publish documents according to global health authority requirements.
  • Maintain Compliance: Ensure adherence to regulatory guidelines (FDA, EMA) and internal processes to guarantee submission quality.
  • Perform QC and Track Timelines: Conduct thorough file structure reviews, hyperlinks, and metadata checks, and track submission timelines to meet regulatory deadlines.

Requirements:

  • Veeva Vault eCTD Publishing Expertise: Strong experience in utilizing Veeva Vault eCTD Publishing for submissions is essential.
  • Global Regulatory Knowledge: Familiarity with global regulatory requirements (FDA, EMA) is required.
  • eCTD Sequences and Ready Dossiers: Hands-on experience in preparing eCTD sequences and publishing ready dossiers is necessary.
  • Attention to Detail and Organizational Skills: Excellent attention to detail and strong organizational skills are crucial for success in this role.
  • Communication Skills: Good communication skills to collaborate with multiple stakeholders are essential.
  • Life Sciences/Pharma Regulatory Experience: Prior experience in Life Sciences/Pharma regulatory publishing is mandatory.

Why Work with Us?

We offer a dynamic and supportive work environment where you can contribute to creating high-quality submissions that help bring innovative products to market.

About the Role:

This is an excellent opportunity to grow your career in regulatory publishing and work with a talented team of professionals who share your passion for regulatory excellence.

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