Global Regulatory Lead

il y a 4 jours


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

Job Title: Regulatory Affairs Senior Lead

Company: Ividata Life Sciences

Job Summary:

We are seeking a highly experienced Regulatory Affairs Senior Lead to join our team at Ividata Life Sciences. As a key member of our Global Regulatory Team, you will be responsible for ensuring the successful delivery of regulatory strategies and submissions across major markets.

Key Responsibilities:

  • Develop and implement regulatory strategies to support the delivery of the Target Product Profile
  • Collaborate with internal stakeholders to ensure consistency and timely delivery of regulatory documentation throughout the product life cycle
  • Design and implement regulatory submission plans in collaboration with submission management and regional leads
  • Oversee the development and maintenance of the Reference Dossier and ensure updates for line extensions, market expansion, and variations
  • Provide support to RRL/LRA in key markets to facilitate registration procedures
  • Interface with external partners, including CDx providers and licensing partners
  • Lead regulatory impact assessments in case of new findings

Requirements:

  • Advanced degree in a relevant scientific discipline or equivalent experience
  • Master of Sciences (M/S), Pharm D, PhD/MD preferred
  • Knowledgeable in ICH, FDA, and EMA guidelines and requirements
  • Fluent in English; good knowledge of French is an advantage
  • Minimum of 5 years' experience in managing regulatory processes and registration aspects of the drug development process
  • Prior experience as an experienced Global Regulatory Lead is preferred

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