Pharmaceutical Regulatory Affairs Specialist

1 month ago


London, Greater London, United Kingdom Novartis Full time
Global Regulatory Publishing Specialist

We are seeking a highly skilled Global Regulatory Publishing Specialist to join our Regulatory Operations Team at Novartis. As a key member of our team, you will be responsible for publishing, verifying, and dispatching clinical documents and submission dossiers worldwide.

Key Responsibilities:

  • Prepare and publish clinical documents and submission dossiers in compliance with worldwide health authority requirements.
  • Verify and validate electronic clinical document publishing standards and formats.
  • Coordinate and dispatch global regulatory submissions in support of Novartis product portfolios.
  • Produce high-quality clinical deliverables and global submission outputs within agreed timelines.
  • Support the implementation of new technology, tools, and processes to improve efficiency and quality.

Requirements:

  • Bachelor's degree in life sciences or relevant discipline.
  • Clinical report and global submission dossier publishing/compilation experience in the pharmaceutical or related industry.
  • Working knowledge of electronic clinical document publishing standards, formats, and global submission validation tools.
  • Fluency in English.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.



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