At Sanofi, we value diversity, inclusion, and professional development. We offer competitive benefits, international mobility opportunities, and a supportive culture that fosters innovation.
Job Description
Key Responsibilities:
As an R&D Ancillary Document Coordinator, you will play a crucial role in managing regulatory documentation for global submissions. Your responsibilities include:
✔ Ancillary Document Management:
- Request, track, and manage ancillary documents required for regulatory submissions.
- Ensure compliance with regional and international regulatory standards.
- Collaborate with vendors and stakeholders to maintain document tracking tools.
✔ Regulatory Expertise:
- Advise teams on ancillary document regulations to ensure compliance.
- Draft and review Certificates of Pharmaceutical Product (CPP) forms.
- Upload and manage documents in Vault RIM with accurate metadata.
✔ Process Improvement:
- Work with Global Regulatory Affairs (GRA) and Digital teams to enhance document management systems.
- Identify opportunities for process optimization and efficiency.
✔ Cross-functional Collaboration:
- Partner with internal teams and external vendors to ensure timely submission of high-quality dossiers.
About You
Qualifications & Skills:
✅ Bachelor’s degree in Regulatory Affairs, Life Sciences, or related field.
✅ 2+ years of experience in Pharmaceutical Regulatory Operations/Regulatory Affairs.
✅ Strong knowledge of regulatory dossier requirements and document management systems (Vault RIM, MS Office, Adobe Acrobat).
✅ Excellent project management, attention to detail, and communication skills.
✅ Proficiency in English (written & spoken).
Why Join Us?
🌟 Innovative Work Environment: Contribute to groundbreaking healthcare solutions.
🌍 Global Career Growth: Opportunities for international mobility.
💼 Competitive Benefits: Health & wellness programs, parental leave, and rewards.
🤝 Inclusive Culture: Equal opportunities for all employees.
