Regulatory Document Specialist

23 hours ago

Hubli, Karnataka, India beBeePublishing Full time ₹ 9,00,000 - ₹ 15,00,000

Key Responsibilities:

  • Prepare and manage biologics license applications in electronic common technical document format using a specialized software platform.
  • Compile, format, and publish regulatory documents according to global health authority requirements.
  • Ensure compliance with regulatory guidelines and internal processes.
  • Perform quality control of electronic common technical document submissions, including file structure, hyperlinks, and metadata.
  • Collaborate with cross-functional teams to gather and manage content.
  • Track submission timelines and deliverables to meet regulatory deadlines.

Required Skills & Qualifications:

  • Strong experience in electronic common technical document publishing for biologics license applications.
  • Knowledge of global regulatory requirements.
  • Hands-on experience in preparing electronic sequences and publishing ready dossiers.
  • Attention to detail with strong organizational skills.
  • Good communication skills to collaborate with multiple stakeholders.
  • Prior experience in life sciences/pharmaceutical regulatory publishing is mandatory.

Job Highlights:

As a regulatory publishing specialist, you will be responsible for ensuring the accuracy and completeness of regulatory documents submitted to global health authorities. You will work closely with cross-functional teams to gather and manage content, track submission timelines, and perform quality control checks on electronic submissions. If you have experience in electronic common technical document publishing and are looking for a challenging role that involves working with regulatory documents, this may be the job for you.

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