Director, RA Global Regulatory Strategy

Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. The role leads the Global Regulatory Product Team (GRPT) and may serve various cross‑functional team roles including Area Lead (US/Canada) and Labeling Regulatory Strategy Team (LRST). The Director ensures strategic messaging in global regulatory dossiers and responses, serves as the primary regulatory interface, maintains compliance with global regulatory requirements, and manages compounds through all phases of development and life cycle. Responsibilities Interface with LRST and AST to implement cross‑functional company objectives. Lead the GRPT in developing creative global strategies aligned with regulations. Ensure inclusion of appropriate strategic messaging in global regulatory dossiers and responses to agency requests. Act as key internal leader and driver of regulatory policy and strategy for assigned products. Prepare and maintain global regulatory product strategies and risk assessment/mitigation plans. Analyze legislation, regulations, and guidance; provide analysis to the organization. Develop and implement regulatory record‑keeping policies and procedures. Present regulatory assessments and recommendations to executive management. Make decisions regarding work processes or operational plans to achieve program objectives. Follow budget allocations and keep the supervisor informed on project resourcing. Qualifications Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology or related). Preferred advanced degree and certification. 5+ years of regulatory experience, including 3+ years in a strategic leadership role with strong project management skills. Experience in a complex, matrix environment with multiple stakeholders and interfaces with government regulatory agencies. Strong communication, negotiation, and business acumen; able to work under pressure. Preferred 7+ years in pharmaceutical regulatory activities, experience with at least two regions or major countries, and successful global regulatory strategy development. Drug development experience and a strong clinical foundation preferred. Benefits Base pay range defined by job grade; actual pay may vary by location. Comprehensive benefits package including paid time off, medical/dental/vision insurance, and a 401(k) plan. Eligibility to participate in short‑term incentive programs. Equal Employment Opportunity Statement AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. #J-18808-Ljbffr