Regulatory Affairs Senior Lead

il y a 6 jours


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

We are seeking a highly skilled Regulatory Affairs Senior Lead to join our team at Ividata Life Sciences. As a key member of our regulatory team, you will be responsible for developing product information and Company Core Data Sheets (CCDS) in collaboration with our labeling representatives.

Key Responsibilities
  • Design and implement regulatory submission plans in collaboration with submission management and regional leads.
  • Work closely with cross-functional teams to ensure compliance with regulatory requirements.
  • Develop and maintain strong relationships with regulatory agencies and stakeholders.
  • Stay up-to-date with changing regulatory requirements and ensure our products remain compliant.
Requirements
  • Advanced degree in a relevant scientific discipline or equivalent experience.
  • Master of Sciences (M/S), Pharm D, or PhD/MD preferred.
  • Fluent in English, with good knowledge of French an advantage.
  • Experience with product life cycles and regulatory submissions a plus.

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