Regulatory Publishing Expert

2 days ago

Gurgaon, Haryana, India beBeePublishing Full time ₹ 18,00,000 - ₹ 25,00,000

Job Description:

Publishing Manager

Lead and oversee the planning, preparation, publishing, and dispatch of regulatory submissions in eCTD and non-eCTD formats to global health authorities. Ensure submission compliance and quality, providing leadership in workload management, publishing strategy, and adoption of new tools and technologies to streamline the submission process.

Main Responsibilities:
  • Oversee end-to-end publishing activities for major and minor submissions.
  • Ensure compliance with global health authority requirements.
  • Perform document formatting, hyperlinking, bookmarking, and validation using industry-standard publishing tools.
  • Ensure on-time dispatch of submission packages via electronic gateways.
Requirements:

Mandatory Skills and Qualifications:

  • Master's degree in Pharmacy or Life Sciences preferred.
  • 6-10 years of hands-on regulatory publishing experience in eCTD and non-eCTD formats.
  • Expertise in CTD eCTD structure, regional specifications, and global submission requirements.
  • Proficiency with industry-leading publishing tools and validation tools.
Benefits:

We provide robust benefits and opportunities to foster personal and professional growth. Your success and well-being are our top priorities.

Why Join Us:

A collaborative environment where you can grow at every step, take charge of your journey, and thrive in a supportive community.

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