
Regulatory Publishing Specialist
5 days ago
Regulatory Publishing Specialist Opportunity
- Prepare and manage submissions in electronic format using Veeva Vault.
- Compile, format, and publish regulatory documents according to global health authority requirements.
Main Responsibilities:
- Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
- Perform quality control of electronic 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.
Skill Requirements:
- Strong experience in Veeva Vault for submissions.
- Familiarity with global regulatory requirements (FDA, EMA).
- Hands-on experience in preparing sequences and publishing 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 essential.
Key Skills:
- eCTD publishing
- regulatory compliance
- quality control
- cross-functional collaboration
- submission management
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