The Associate Director, GRS PMDH leads global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products across therapeutic areas
Job Summary
The Associate Director, GRS PMDH leads global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products across therapeutic areas.
This role involves assessing regulatory landscapes, managing regulatory risks, and developing global filing strategies, co-leading marketing application submission teams, and ensuring consistent responses to global Health Authority (HA) queries.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment and offers a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals.
Matching Summary
The Associate Director, GRS PMDH leads global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products across therapeutic areas.
Salary
Base: zł361,740 - zł438,337; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Competitive benefits, services and programs
Skills & Requirements
Must-have
global regulatory strategies
biomarkers and companion diagnostics
digital health solutions
marketing application submission teams
health authority queries
protocol development input
Nice-to-have
transforming patients' lives
balance and flexibility
collaboration and innovation
supportive culture
Key Requirements
7 years US or EU Medical Device Regulatory Affairs experience