Leadership at a top-tier pharmaceutical client has exclusively tasked Junto HLS with recruiting a Director, Regulatory Affairs to oversee and execute all regulatory activities for multiple projects and support regulatory activities for assigned market products.
- Leads the regulatory working team and serves as regulatory lead on the global development team; ensures global regulatory strategy is written and executed according to plan
- Responsible for all US FDA submissions and approvals of project(s) of responsibility
- Provides oversight to ensure regulatory compliance of marketed products
- Collaborates with regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside the Americas to ensure regional execution of the strategy
- Responsible for identifying regulatory requirements and providing regulatory guidance, and expertise to global development team
- Leads and manages FDA meetings
- Greater Chicago, IL
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.