International Regulatory Affairs Project Manager

Recordati Industria Chimica e Farmaceutica S.p.A

Regulatory strategy
Dossier management
Compliance monitoring
Responsible for securing new product registrations and maintaining existing marketing authorizations with global Health Authorities

Job Summary

  • Responsible for securing new product registrations and maintaining existing marketing authorizations with global Health Authorities.
  • Acts as a critical link between the company, subsidiaries, and international partners to ensure compliance with global regulatory standards.
  • Represents the company at external meetings and provides detailed reporting to senior management.

Matching Summary

Responsible for securing new product registrations and maintaining existing marketing authorizations with global Health Authorities.

Skills & Requirements

Must-have

  • Regulatory strategy
  • Dossier management
  • Compliance monitoring
  • Stakeholder communication
  • Global filings
  • Regulatory submissions

Nice-to-have

  • Rare disease experience
  • Niche market expertise
  • Cross-functional collaboration

Key Requirements

  • University Degree in Pharmacy or related field
  • 4-5 years of experience in Pharmaceutical Industry
  • Experience in Rare Disease field or Niche Markets
  • Proven experience with pre-approval and post-approval dossiers
  • Fluency in English

Work Rights

Not specified

Tailored Resume

Cover Letter