Ectd Document Manager

6 days ago

Thiruvananthapuram, Kerala, India beBeeExperience Full time ₹ 90,00,000 - ₹ 1,50,00,000

Job Title: Regulatory Publishing Specialist

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We are seeking a highly skilled Regulatory Publishing Specialist to join our team. As a key member of our regulatory publishing team, you will be responsible for preparing and managing BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.

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  • We are looking for someone with strong experience in Veeva Vault eCTD Publishing for BLA submissions.

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  • Knowledge of global regulatory requirements is essential, including FDA and EMA guidelines.

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  • Hands-on experience in preparing eCTD sequences and publishing ready dossiers is required.

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  • You will need to have attention to detail and strong organizational skills to ensure timely submission and delivery of high-quality documents.

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  • Good communication skills are necessary to collaborate effectively with cross-functional teams, including Regulatory, Clinical, and CMC teams.

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  • Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.

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Responsibilities:

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  • Prepare and manage BLA submissions in eCTD format using Veeva Vault eCTD Publishing.

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  • Compile, format, and publish regulatory documents according to global health authority requirements.

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  • Ensure compliance with regulatory guidelines and internal processes.

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  • Perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.

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  • Collaborate with cross-functional teams to gather and manage content.

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  • Track submission timelines and deliverables to meet regulatory deadlines.

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Required Skills & Qualifications:

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  • Strong experience in Veeva Vault eCTD Publishing for BLA submissions.

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  • Knowledge of global regulatory requirements (FDA, EMA).

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  • Hands-on experience in preparing eCTD sequences and publishing ready dossiers.

    ">

  • Attention to detail with strong organizational skills.

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  • Good communication skills to collaborate with multiple stakeholders.

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  • Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.

    ">
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