Senior Subject Matter Expert, DMPK, Sr/Exe Director

Key Responsibilities:

• Serve as the global DMPK regulatory strategy lead for complex drug development programs, ensuring alignment with international regulatory requirements (e.g., FDA, EMA, NMPA).
• Provide expert advice and oversight on DMPK-related sections of IND, NDA, and other regulatory dossiers, with a focus on supporting teams in China.
• Lead interactions and negotiations with regulatory authorities (FDA, EMA, etc.) on DMPK-related matters, including pre-IND/NDA meetings, written responses, and advisory committee meetings.
• Mentor and train junior scientists and project teams on DMPK regulatory strategies, submission best practices, and emerging global trends.
• Collaborate with business development and project management teams to support client engagements, proposal development, and market expansion initiatives, particularly in the U.S. and Europe.
• Maintain and enhance the company's scientific reputation through publications, conference presentations, and active participation in industry working groups.
• Stay abreast of evolving regulatory guidelines and industry standards to ensure cutting-edge, compliant strategies.

MPI does not discriminate on the basis of race, religion, sex, sexual orientation, gender identity or expression, age, disability, marital status, or based on an individual's status in any group or class otherwise protected under applicable human rights legislation. MPI encourages applications from minorities, women, the disabled and all other qualified applicants.