Senior Manager, Regulatory Intelligence - Regeneron Ireland DAC
  • Dublin, Leinster, Ireland
  • via BeBee.com
-
Job Description

**Regulatory Intelligence Lead** This role involves leading complex global monitoring and surveillance of regulatory changes in the drug development lifecycle, from preclinical to commercialization. **Key Responsibilities:** * Lead project management and delivery of regulatory intelligence research services and information * Collaborate on developing and refining regulatory intelligence processes and procedures * Manage complex intelligence query requests from internal stakeholders * Serve as functional lead on cross-functional organizational level projects or initiatives * Monitor and analyze global regulatory intelligence sources for current changes and information in the drug development space * Assess regulatory intelligence information for relevance and impact to company processes, drug development projects, and regulatory strategies * Identify business critical aspects and communicate effectively to internal stakeholders * Support project teams, functions, and departments through the collection and distribution of requested regulatory intelligence information * Provide regulatory intelligence in support of operational study design and operational planning activities **Requirements:** * Advanced life science degree or related field * Minimum of 6+ years experience in the biotech/pharmaceutical industry with a strong focus in Regulatory Intelligence * Good understanding of the drug development and commercialization process, with a focus on clinical development and trial execution * Experienced in understanding and interpreting regulatory guidelines and documents * Ability to research, analyze, and extrapolate critical regulatory information, with a focus on clinical requirements and recommendations **Company Overview:** Regeneron is a leading biotechnology company that provides comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. We have an inclusive and diverse culture that values equality and diversity. **Salary Range:** $129,800.00 - $211,800.00 annually

;