Associate Director, PMDH

Bristol Myers Squibb is looking for an Associate Director, PMDH to lead global regulatory strategies for the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices. The role requires a strong background in regulatory affairs, team leadership, and project management within the medical device and pharmaceutical industries.

Requirements

• Leadership responsibility for global regulatory strategy
• Understanding of regulatory landscape, assessing regulatory risk, and developing global filing strategies
• Co-leading marketing application submission teams
• Ensuring consistent positions in responses to global Health Authority queries
• Developing global submission plans and HA interaction plans
• Providing input into protocol development and contributing to the development of target labeling

Benefits

• Competitive benefits
• Services and programs for work-life balance
• Flexible work environment
• Opportunities for growth and development