Veeva eCTD BLA Publisher

2 weeks ago


Hyderabad, Telangana, India Zensar Technologies Full time ₹ 5,00,000 - ₹ 15,00,000 per year

We are seeking a passionate and detail-oriented Veeva eCTD BLA Publisher to support global regulatory submissions for biologics and BLA products. The ideal candidate will have hands-on experience with Veeva Vault eCTD Publishing , strong knowledge of FDA and EMA guidelines , and a proven track record of compiling, formatting, and dispatching high-quality eCTD submissions.

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.
  • Respond to agency queries and manage feedback using tools like SharePoint, Communicator, and email systems .

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


  • Hyderabad, Telangana, India, Telangana PeopleLogic Full time

    Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.Hands-on experience with Docubridge and Lorenz Validator for regulatory submissions.Strong background in Regulatory Publishing with knowledge of global regulatory requirements (FDA, EMA).Experience in Life Sciences / Pharma regulatory...

  • Veeva CRM

    2 weeks ago


    Hyderabad, Telangana, India LTIMindtree Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role: Veeva CRM - TestingExperience: 5-8 yrsLocation: Pan IndiaNotice Period: Immediate to 15 daysKey ResponsibilitiesPerform functional regression and integration testing on Veeva CRM applicationsValidate workflows including approval chains content publishing and analytics trackingCollaborate with business analysts and developers to understand requirements...


  • Hyderabad, Telangana, India Makrocare Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Education: Bachelors Degree in Life Sciences or related fieldMarkets: US/UK/EU/ROW Job Summary:We are seeking a detail-oriented and proactive Associate - Regulatory Affairs (RA) Publishing with 1-3 years of experience in regulatory submissions across global markets including the US, UK, EU, and ROW (Rest of World). The ideal candidate will have a background...

  • Veeva CRM

    7 days ago


    Hyderabad, Telangana, India, Telangana LTIMindtree Full time

    Role: Veeva CRM - TestingExperience: 5-8 yrsLocation: Pan IndiaNotice Period: Immediate to 15 daysKey ResponsibilitiesPerform functional regression and integration testing on Veeva CRM applicationsValidate workflows including approval chains content publishing and analytics trackingCollaborate with business analysts and developers to understand requirements...


  • Hyderabad, Telangana, India Amgen Inc Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    ABOUT THE ROLEThe Regulatory Affairs Senior Associate role assists US Promotion Regulatory representatives and other cross-functional roles in the administration of regulatory strategies for department initiatives across all product brands. This role assists with preparing, tracking, reporting, and archiving US regulatory documentation, including...

  • Regulatory Affairs

    6 days ago


    Hyderabad, Telangana, India Shilpa Medicare Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Role & responsibilitiesCMC and Labelling:Preparation of ANDAs in eCTD format for various type of formulationsReview of the technical documents such as Specifications, BMR, MFC,Able to work on All type of CTD section write-upsHands on experience on life cycle management activity (AR, CBE, CBE-30 and PAS)Through knowledge on ICH guidancesShould able to handle...


  • Hyderabad, Telangana, India Amgen Inc Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    *What you will do* In this vital role you will set platform-wide architectural guardrails, ensure every Vault shares a scalable, compliant foundation, and translate complex business needs into elegant, reusable designs that accelerate R&D, Quality, Safety, Medical and Commercial outcomes.Roles & Responsibilities: Define and maintain the enterprise...


  • Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    What you will doThe Veeva Vault Release Manager will spearhead Veeva change and release management initiatives within Amgens Veeva Vault ecosystem. This role focuses primarily on change and release management, encompassing the planning, scheduling, and deployment of changes and releases across various Veeva Vault in Amgen. As the key point of contact, you...


  • Hyderabad, Telangana, India MSD Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job DescriptionResponsible for implementing CMC regulatory strategies for assigned products inaccordance with global regulations and guidances; and is responsible for thepreparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of regulatory milestones for less complex projectsthrough the product...


  • Hyderabad, Telangana, India MSD Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Job DescriptionResponsible for implementing CMC regulatory strategies for assigned products inaccordance with global regulations and guidances; and is responsible for thepreparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of regulatory milestones for less complex projectsthrough the product...