
Veeva eCTD Regulatory Publishing Expert
2 days ago
As a Regulatory Publishing Specialist, you will play a pivotal role in preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
You will be responsible for compiling, formatting, and publishing regulatory documents according to global health authority requirements.
Ensuring compliance with regulatory guidelines (FDA, EMA) and internal processes is crucial in this position.
You will perform quality control of eCTD submissions, including file structure, hyperlinks, and metadata.
Collaboration with cross-functional teams to gather and manage content is essential in this role.
Tracking submission timelines and deliverables to meet regulatory deadlines is also a key responsibility.
Required Skills & Qualifications:- Experience in Veeva Vault eCTD Publishing for BLA submissions.
- Knowledge of global regulatory requirements (FDA, EMA).
- 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.
- Experience in Life Sciences / Pharma regulatory publishing is mandatory.
The successful candidate will have a strong understanding of eCTD regulations and procedures, as well as excellent communication and organizational skills.
They will be able to work effectively in a team environment and prioritize tasks to meet deadlines.
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