Global Regulatory Lead, Biomarkers & Digital Health

Bristol-Myers Squibb; Województwo mazowieckie; Hybrid; PLN 150,000 - 180,000; Full time

Job summary

A global biopharmaceutical company in Poland seeks an Associate Director to lead regulatory strategies for biomarkers and other devices. This role requires a strong regulatory affairs background and experience with medical devices. Responsibilities include managing regulatory risks and leading submission teams while fostering a collaborative environment. Competitive benefits and opportunities for career growth are offered.

Qualifications

• At least 7 years of US or EU Medical Device Regulatory Affairs experience.
• Strong background in regulatory affairs, team leadership, and project management.

Responsibilities

• Lead global regulatory strategy for medical devices and biopharmaceuticals.
• Manage regulatory risks and develop global filing strategies.
• Co-lead teams for marketing application submissions and maintain consistency in responses.

Skills

Leadership skills

Regulatory strategy development

Project management

Communication skills

Conflict resolution

Education

Bachelor’s degree in a relevant field

Advanced scientific degree preferred (Masters, PhD, PharmD, BSN)

Job description

A global biopharmaceutical company in Poland seeks an Associate Director to lead regulatory strategies for biomarkers and other devices. This role requires a strong regulatory affairs background and experience with medical devices. Responsibilities include managing regulatory risks and leading submission teams while fostering a collaborative environment. Competitive benefits and opportunities for career growth are offered.