
BLA Submission Specialist – eCTD Publishing Professional
1 week ago
We are seeking a skilled professional to join our team. The successful candidate will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
Key Responsibilities:- Compile, format, and publish regulatory documents according to global health authority requirements.
- Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
- Perform quality control of eCTD submissions, including file structure, hyperlinks, and metadata.
- Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.
- Track submission timelines and deliverables to meet regulatory deadlines.
- Strong 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.
- Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.
As a Regulatory Publishing Specialist, you will play a critical role in ensuring the success of our product submissions. You will have the opportunity to work closely with our cross-functional teams to develop and implement effective regulatory strategies.
In this role, you will be responsible for preparing and publishing high-quality regulatory documents that meet global health authority requirements. You will also ensure compliance with regulatory guidelines and internal processes, and perform quality control checks on eCTD submissions.
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