
BLA Regulatory Publishing Specialist – eCTD Expert
14 hours ago
We are seeking a skilled Regulatory Publishing Specialist to join our team.
Key Responsibilities:
- Prepare and manage BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
- Compile, format, and publish regulatory documents according to global health authority requirements.
- Ensure compliance with regulatory guidelines and internal processes.
- Perform QC 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.
Required 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 mandatory.
About the Role:
The Regulatory Publishing Specialist will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing. This includes compiling, formatting, and publishing regulatory documents according to global health authority requirements while ensuring compliance with regulatory guidelines and internal processes.
This role requires strong experience in Veeva Vault eCTD Publishing for BLA submissions, knowledge of global regulatory requirements, and hands-on experience in preparing eCTD sequences and publishing ready dossiers. The successful candidate will have attention to detail with strong organizational skills and good communication skills to collaborate with multiple stakeholders.
What We Offer:
- A dynamic work environment with opportunities for growth and development.
- A competitive salary and benefits package.
- The chance to work with a talented team of professionals.
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