
Regulatory Publishing Specialist
4 days ago
Job Summary
">We are seeking a highly skilled Regulatory Publishing Specialist to join our team. In this role, you will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
">Key Responsibilities:
">- ">
- Submission Preparation: Compile, format, and publish regulatory documents according to global health authority requirements.">
- Quality Control: Perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.">
- Collaboration: Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.">
- Project Management: Track submission timelines and deliverables to meet regulatory deadlines.">
Required Skills & Qualifications:
">- ">
- Veeva Experience: Strong experience in Veeva Vault eCTD Publishing for BLA submissions is mandatory.">
- Regulatory Knowledge: Knowledge of global regulatory requirements (FDA, EMA) is essential.">
- eCTD Sequencing: Hands-on experience in preparing eCTD sequences and publishing ready dossiers is required.">
- Attention to Detail: Attention to detail with strong organizational skills is necessary.">
- Communication: Good communication skills to collaborate with multiple stakeholders are essential.">
- Life Sciences Background: Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.">
About the Role:
">This is an exciting opportunity for a highly motivated and experienced Regulatory Publishing Specialist to join our team.
">We Offer:
">A competitive salary and benefits package, as well as opportunities for professional growth and development.
">If you are a driven and detail-oriented individual with a passion for regulatory publishing, we encourage you to apply.
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