eCTD Regulatory Publishing Specialist

2 weeks ago

Bikaner, Rajasthan, India beBeePublishing Full time ₹ 10,00,000 - ₹ 15,00,000

Regulatory Publishing Specialist for eCTD Submissions

Job Description

As a Regulatory Publishing Specialist, you will be responsible for managing BLA submissions and compiling regulatory documents in accordance with global health authority requirements.

  • Manage the creation and publication of regulatory documents
  • Perform quality control on eCTD submissions to ensure compliance with regulatory guidelines
  • Collaborate with cross-functional teams to gather and manage content

Key Responsibilities:

  • Compile and publish regulatory documents according to global health authority requirements
  • Ensure compliance with regulatory guidelines and internal processes
  • Perform quality control of eCTD submissions, including file structure, hyperlinks and metadata
Required Skills & Qualifications

To be successful in this role, you will need:

  • Experience in Veeva Vault eCTD Publishing for BLA submissions
  • Knowledge of global regulatory requirements
  • Hands-on experience in preparing eCTD sequences and publishing ready dossiers

The ideal candidate will have a strong understanding of the eCTD sequence and be able to manage complex projects. Strong attention to detail and excellent communication skills are also essential. This role requires collaboration with cross-functional teams to ensure timely delivery of high-quality submissions.

Benefits

This role offers a unique opportunity to work in a dynamic environment and contribute to the success of our organization.

By joining our team, you will gain valuable experience in regulatory publishing and develop your skills in project management and teamwork.

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