Director, RA Global Regulatory Strategy

About the Role

The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT) and ensures strategic messaging and content of global regulatory dossiers.

• Interface with the LRST and AST to lead and support cross‑functional company objectives.
• Lead the GRPT to develop creative global strategies in line with applicable regulations to achieve business objectives for development and market‑approved products.
• Lead cross‑functional stakeholders and regulatory professionals to include appropriate and clear strategic messaging in global regulatory dossiers and responses to regulator requests.
• Accountable for ensuring corporate goals are met and act as a key internal leader and driver of regulatory policy and strategy for assigned products.
• Lead preparation of global regulatory product strategies and lead teams in risk assessment, mitigation strategy development, and communication of plans to stakeholders.
• Act independently under direction of a GRS Sr GRL or TA Head and may participate in or lead regulatory and company initiatives, expand TA knowledge, and provide coaching for GRPT members.
• Influence the development of regulations and guidance and analyze legislation, regulations, and guidance to provide analysis for the organization.
• Follow company policies for regulatory record‑keeping and identify needs for policy and procedural improvements within the RA department.
• Present meaningful regulatory assessments and recommendations to executive management and inform cross‑functional management of issues, labeling outcomes, and risk mitigation.
• Make decisions regarding work processes or operational plans to achieve program objectives and represent ABBV Regulatory position in joint governance interactions.
• Follow budget allocations, manage project resourcing, and chair or sponsor key GRS initiatives.

• Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or a related field.
• Preferred Education: Advanced degree preferred; certification in the field a plus.
• Experience: 7+ years of regulatory experience, including 5+ years in a strategic leadership role, strong project management skills, and experience in a complex matrix environment with multiple stakeholders.
• Preferred Experience: 10+ years in pharmaceutical regulatory activities, experience leading regulatory strategy in multiple major regions (e.g., US, EU, Japan), and a strong global drug development foundation.

• Compensation range for this role is a base pay range that may vary by location and experience.
• Benefits include paid time off (vacation, holidays, sick leave), medical, dental, and vision insurance, and a 401(k) retirement plan.
• Eligible to participate in long‑term incentive programs.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, and serving our community. Equal Opportunity Employer / Veterans / Disabled.