Associate Director, Regulatory Affairs

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Description

• Proactively develop and execute creative and thorough global regulatory strategies for assets in clinical development through collaborative partnership and regulatory leadership within the project team
• Ability to assess and develop solutions for complex regulatory challenges
• Function as a strategic regulatory partner within the cross-functional project team to execute on program strategies and deliverables
• Server as the regulatory point of contact for assigned projects.
• Support and lead development and strategy of regulatory documents submissions to CTAs, INDs, NDAs/BLAs, and MAAs
• Support and lead interactions with regulatory authorities
• Ensure timely communication of relevant program topics and issues to regulatory affairs management.
• Ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate.