
Biologics Regulatory Document Manager
3 days ago
We are seeking a highly skilled Regulatory Publishing Specialist to join our team.
Key Responsibilities:
- Publishing Regulatory Documents: Format and publish regulatory documents according to global health authority requirements, ensuring compliance with FDA and EMA regulations.
- eCTD Submission Management: Utilize Veeva Vault eCTD Publishing to create and manage Biologics License Applications in eCTD format, meeting critical regulatory deadlines.
- Quality Control: Verify eCTD submissions for accuracy, including file structure, hyperlinks, and metadata.
- Cross-Functional Collaboration: Work with Regulatory, Clinical, and CMC teams to gather and manage content, promoting effective communication and project success.
Required Skills & Qualifications:
- Veeva Vault Experience: Proven experience in preparing BLA submissions using Veeva Vault eCTD Publishing, with a strong understanding of eCTD sequences and dossiers.
- Global Regulatory Knowledge: Comprehensive knowledge of global regulatory requirements, including FDA and EMA guidelines.
- eCTD Sequences and Dossiers: Hands-on experience in preparing eCTD sequences and publishing ready dossiers, with a focus on attention to detail and organizational skills.
- Life Sciences Background: Prior experience in Life Sciences / Pharma regulatory publishing is essential, with a strong foundation in scientific principles and regulatory frameworks.
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