Pharmaceutical Regulatory Affairs Specialist
1 month ago
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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