Associate Director Global Regulatory Affairs

 

Leadership at a top-tier pharmaceutical client has exclusively tasked Junto HLS with recruiting an Associate Director Global Regulatory Affairs to oversee and execute all regulatory activities for multiple projects and support regulatory activities for assigned market products.

Select Accountabilities:

  • Leads the regulatory working team and ensures regulatory strategy is written and executed according to plan
  • 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
  • Develops/authors and executes global regulatory strategies for more complex strategies
  • Leads and manages regulatory authority interactions/meetings
  • Responsible for achieving all submissions levels, including major submissions (NDA/BLA/MAA)
  • Provides oversight to ensure regulatory compliance of marketed products
  • Oversees multiple projects and manages individual projects

Location(s):

  • 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 Michelle@junto.itprospect.in.