
Regulatory Publishing Specialist
3 days ago
Job Summary:
We are seeking a highly skilled Regulatory Publishing Specialist to join our team. The ideal candidate will have strong experience in Veeva Vault eCTD Publishing and knowledge of global regulatory requirements.
Key Responsibilities:
- Manage the preparation and submission of BLA documents in eCTD format.
- Compile and publish regulatory documents for global health authorities.
- Ensure compliance with regulatory guidelines and internal processes.
- Perform quality control checks on eCTD submissions.
- Collaborate with cross-functional teams to gather and manage content.
- Track submission timelines and deliverables.
Required Skills & Qualifications:
- Strong experience in Veeva Vault eCTD Publishing.
- Knowledge of global regulatory requirements.
- Hands-on experience in preparing eCTD sequences.
- Attention to detail and strong organizational skills.
- Good communication skills to collaborate with stakeholders.
Benefits:
- Prior experience in Life Sciences/Pharma regulatory publishing is mandatory.
About Us:
We strive to meet the highest standards of quality and compliance in our work.
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