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Senior Global RA Professional
3 days ago
This is an exceptional opportunity to join Chiesi's fast-growing and dynamic team as a Senior Global RA Manager. You will be responsible for leading the Global Regulatory Team and serving as the regulatory representative on global core teams for assigned projects.
Key Responsibilities:
- Drive the development of innovative and robust regulatory strategies for new and existing products, ensuring compliance with internal and external regulatory standards.
- Collaborate with cross-functional teams to manage pre-approval and post-approval activities, providing strategic guidance to clinical, pre-clinical, and CMC development teams.
- Maintain strong relationships with health authorities, staying up-to-date on relevant regulations and requirements.
- Support affiliates and partners on prioritized issues and topics, leveraging your expertise to drive project success.
Requirements:
- At least ten years of experience within Regulatory Affairs, with at least five in a regional or global context.
- University degree in a scientific discipline, such as Chemistry, Pharmacy, Human Medicine, Biological Science, or Biotechnology.
- Written and spoken English for professional purposes.
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