Regulatory Affairs Specialist

**Company Description**
**Major Responsibilities**:
- Provides strategic direction to support the development of compliant and competitive Regulatory programs;
- Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines to drive complete and timely information to Health Authorities;
- Effectively incorporates country-specific regulatory requirements, guidance, and other relevant regulatory intelligence into Regulatory submissions across the Area;
- Interacts with GRPTs and other key stakeholders across the enterprise to ensure regulatory milestones are properly communicated; provides timely updates on progress and/or issues that may impact the global program;
- Leads ARPTs to ensure that Regulatory programs can be effectively carried forward across all countries within the Area;
- Interacts with stakeholders across functions to ensure that Regulatory strategies are aligned with enterprise busines...