Regulatory Affairs Specialist

il y a 3 jours


Paris, Île-de-France IVDATA Life Sciences Temps plein
Job Title: Regulatory Affairs Specialist

At IVDATA Life Sciences, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines across major markets.

Key Responsibilities:
  • Develop and implement regulatory strategies to support product launches and lifecycle management
  • Collaborate with internal stakeholders to ensure consistency and timely delivery of regulatory documentation
  • Interface with external partners, including CDx providers and licensing partners
  • Provide support to RRL/LRA in key markets for registration procedures and to Market Access for core value dossier
  • Lead regulatory impact assessments in case of new findings
Requirements:
  • Advanced degree in a relevant scientific discipline or equivalent experience
  • Knowledgeable in ICH, FDA, and EMA guidelines and requirements
  • Fluent in English, with good knowledge of French an advantage
  • Minimum of 5 years' experience in managing regulatory processes and registration aspects of the drug development process
What We Offer:
  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A competitive salary and benefits package

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