Covenant Compliance Review Analyst responsible for monitoring covenant compliance tests and financial statements. Supporting Relationship Managers with compliance and documentation for commercial clients.
About the role
- Regulatory Strategist at Sanofi developing regulatory product strategies in oncology. Driving regulatory efforts in drug development stages with a focus on compliance and quality input.
Responsibilities
- Provides regulatory expertise and guidance on procedural and documentation requirements
- Liaises with clinical, commercial and other internal business partners
- Contributes to the development of a harmonized regulatory voice at Sanofi
- Proactively contributes with curiosity and openness to diverse perspectives
- Develops, executes and maintains submission content plans
- Effective communication and ability to manage multiple projects/deliverables simultaneously
Requirements
- BS/BA degree in a scientific discipline required (e.g. Biology, Life Science, or related field)
- Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred
- At least 6 years of relevant pharmaceutical/biotechnology industry experience
- At least 6 years of relevant Regulatory Affairs experience or 2 years with an advanced degree
- Understanding of clinical development of drugs and/or innovative biologics products is preferred
- Demonstrated experience with driving the preparation of regulatory documents (e.g. (s)BLA/(s)NDA/MAA, INDs/CTAs)
- Experience with electronic document management systems (e.g. Veeva Vault, Plai) is desirable
Benefits
- High-quality healthcare
- Prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
- Professional development opportunities
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