Associate Director- Established Brands Regulatory Lead

As an Associate Director, Established Brands Regulatory Lead at Bristol Myers Squibb, you will play a crucial role in overseeing the lifecycle of marketed products within the Established Brands portfolio. Your responsibilities will include: - Leading the regulatory strategy for assigned Established Brands assets to maintain marketing authorizations globally - Representing GRS at the Established Brands Global Program Team (GPT) and collaborating with regional and country regulatory leads - Supporting portfolio optimization by identifying regulatory risks, managing response strategies, and ensuring compliance with regulatory requirements - Reviewing Clinical Study Reports, providing content to Safety Aggregate Reports, and addressing regulatory correspondence and postmarketing requirements - Prioritizing and completing multiple projects within established deadlines - Providing regulatory guidance for deletion proposals and asset transitions within the Established Brands Steering Committee - Collaborating with cross-functional teams to resolve regulatory issues and support global and regional needs - Building and maintaining relationships with internal teams to ensure smooth execution of regulatory activities - Staying informed about evolving FDA, EMA, and international regulations and implementing them for assigned projects Qualifications required for this role include: - Scientific background, Ph.D., M.D., PharmD, M.S. in Pharmacy or Life Sciences, or equivalent professional experience - 10+ years of overall pharma experience, including prior positions in Regulatory Affairs/Sciences - Significant experience in managing lifecycle regulatory activities, strong knowledge of regulatory affairs, and experience in driving strategic thinking for successful regulatory outcomes - Excellent interpersonal, organizational, and communication skills, with the ability to work independently in a matrix-driven environment Bristol Myers Squibb values work-life balance and offers competitive benefits to support employees in achieving their personal and professional goals. If you are excited about a role that may not perfectly align with your resume, we encourage you to apply as you could be one step away from a transformative career opportunity.,