Veeva Ectd Bla Publisher

7 days ago

Telangana, India Zensar Technologies Full time

**Key Responsibilities**:

- Prepare, compile, and publish **Biologics License Application (BLA)**submissions in **eCTD format**using **Veeva Vault**and other publishing tools.
- Format regulatory documents (PDFs) in compliance with **ICH and regional specifications**, including **bookmarks, hyperlinks, metadata**, and file naming conventions.
- Perform **quality control (QC)**checks on eCTD sequences to ensure submission readiness.
- Collaborate with cross-functional teams including **Regulatory Affairs, Clinical, CMC, and Safety**to gather and manage submission content.
- Manage **lifecycle submissions**such as initial, variations, AdPromo, Investigator Brochures, Annual Reports, DSURs, and RMPs.
- Track submission timelines and ensure timely delivery to health authorities (FDA, EMA, GCC).
- Maintain working knowledge of **publishing standards**, **document management systems**, and **regulatory compliance tools**.
- Support **XEVMPD/Article 57**activities and ensure product data accuracy in client databases.

**Required Skills & Qualifications**:

- 2-5 years of experience in **regulatory publishing**, specifically with **BLA and biologics submissions**.
- Proficiency in **Veeva Vault eCTD Publishing**, **Docubridge**, **Lorenz Validator**, and **GDMS**.
- Strong understanding of **FDA, EMA, and GCC regulatory requirements**.
- Experience in **eCTD sequence building**, **test publishing**, and **archiving**.
- Familiarity with **XEVMPD**, **SmPC**, **PIL**, and **MedDRA coding**workflows.
- Excellent attention to detail and organizational skills.
- Strong communication skills and ability to work with cross-functional global teams.
- Bachelor’s or Master’s degree in **Pharmacy, Life Sciences, or related field**.

**Preferred Tools & Technologies**:

- Veeva Vault RIM
- Docubridge / eCTD Express
- Lorenz Validator
- Adobe Acrobat Pro
- Microsoft Office Suite
- GDMS / Mediva
- SharePoint / Communicator

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