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Regulatory Lead

Il y a 2 mois

Paris, Île-de-France Ividata Life Sciences Temps plein
Job Summary

We are seeking a highly experienced Global Regulatory Lead to join our team at Ividata Life Sciences. As a key member of our regulatory affairs team, you will be responsible for developing and implementing global regulatory strategies to support the development and commercialization of our products.

Key Responsibilities
  • Regulatory Strategy Development: Develop and implement global regulatory strategies to ensure compliance with regulatory requirements and to support the development and commercialization of our products.
  • Regulatory Intelligence: Stay up-to-date with regulatory trends and developments across major markets, including the US, EU, and Japan.
  • Collaboration and Communication: Collaborate with internal stakeholders, including asset teams and regulatory affairs teams, to ensure alignment and effective communication of regulatory strategies and plans.
  • Regulatory Document Management: Oversee the development and maintenance of regulatory documentation, including product information and company core data sheets.
  • Submission Planning: Work with submission management and regional leads to design and implement regulatory submission plans.
  • Regulatory Agency Interactions: Interface with regulatory agencies, including the FDA, EMA, and PMDA, to ensure compliance and effective communication of regulatory strategies and plans.
Requirements
  • Education: Advanced degree in a relevant scientific discipline, such as a Master of Sciences, Pharm D, or PhD/MD.
  • Experience: Minimum of 5 years' experience in managing regulatory processes and registration aspects of the drug development process.
  • Skills: Knowledge of ICH, FDA, and EMA guidelines and requirements, as well as fluency in English. Good knowledge of French is an advantage.