Global Regulatory Affairs Leader

2 days ago


Stockholm, Stockholm, Sweden Chiesi Farmaceutici S.p.A. Full time
Job Description

As a key member of our R&D team, you will play a vital role in establishing Chiesi Global Regulatory Affairs in Sweden. Your expertise as a Senior Global RA Manager will be instrumental in leading the Global Regulatory Team and serving as the regulatory representative on global core teams for assigned projects.

Key Responsibilities:

  • Leverage your analytical skills to develop innovative and robust regulatory strategies for new and existing products.
  • Collaborate with cross-functional teams to manage pre-approval and post-approval activities, ensuring compliance with internal and external regulatory standards.
  • Maintain strong relationships with health authorities, staying up-to-date on relevant regulations and requirements.
  • Provide strategic guidance to clinical, pre-clinical, and CMC development teams to ensure successful project outcomes.

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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