Veeva eCTD Specialist

Key Responsibilities:

• Manage eCTD Submissions: Prepare and publish regulatory documents in Veeva Vault eCTD Publishing according to global health authority requirements.
• Compile and Format Documents: Gather and organize content from cross-functional teams (Regulatory, Clinical, CMC) for regulatory submissions.
• Maintain Regulatory Compliance: Ensure adherence to regulatory guidelines (FDA, EMA) and internal processes for quality control.
• Perform QC of eCTD Submissions: Verify file structure, hyperlinks, and metadata for accuracy.
• Collaborate with Teams: Work with Regulatory, Clinical, and CMC teams to gather and manage content for submissions.
• Track Timelines and Deadlines: Monitor submission schedules and deliverables to meet regulatory requirements.

Required Skills & Qualifications:

• eCTD Publishing Experience: Strong experience in Veeva Vault eCTD Publishing for BLA submissions.
• Global Regulatory Knowledge: Familiarity with global health authority requirements (FDA, EMA).
• Document Preparation: Hands-on experience in preparing eCTD sequences and publishing ready dossiers.
• Attention to Detail: Strong organizational skills with attention to detail.
• Communication Skills: Good communication skills for collaboration with multiple stakeholders.
• Lifecycle Industry Expertise: Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.

About This Role

This role requires a strong understanding of eCTD submissions and regulatory compliance. The ideal candidate will have experience in Veeva Vault eCTD Publishing and be familiar with global health authority requirements.

The successful candidate will be able to work effectively with cross-functional teams and maintain attention to detail in their work.

We are looking for an experienced professional who can take on this challenging role and contribute to the success of our organization.