
Regulatory Publishing Expert
19 hours ago
Job Opportunity:
We are seeking a skilled Regulatory Publishing Expert to join our team. As an eCTD Specialist, you will play a critical role in preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
About the Role:
- You will be responsible for compiling, formatting, and publishing regulatory documents according to global health authority requirements.
- Ensure compliance with regulatory guidelines and internal processes.
- Perform quality control of eCTD submissions, including file structure, hyperlinks, and metadata.
- Collaborate with cross-functional teams to gather and manage content.
- Track submission timelines and deliverables to meet regulatory deadlines.
Key Skills & Qualifications:
- Strong experience in Veeva Vault eCTD Publishing for BLA submissions.
- Knowledge of global regulatory requirements.
- 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 highly desirable.
What We Offer:
- A dynamic work environment that fosters collaboration and innovation.
- Ongoing training and development opportunities to enhance your skills and expertise.
- The chance to work on high-profile projects and contribute to the success of our organization.
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