Director, RA Global Regulatory Strategy

Job Title: Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy 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 may lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams, proactively anticipates and mitigates regulatory risks, ensures compliance with global regulatory requirements, and manages compounds through all phases of development, including post‑approval and throughout the life cycle of the product. Responsibilities 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 marketed products. Lead cross‑functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory agency requests. Accountable for ensuring that corporate goals are met; key internal leader and driver of regulatory policy and strategy for assigned products. Prepare global regulatory product strategies for assigned products and lead regulatory and cross‑functional teams in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products, communicating plans to relevant stakeholders. Act independently under the direction of a GRS Sr GRL or TA Head; may participate in or lead regulatory and company initiatives. Expand knowledge of therapeutic area, provide coaching and mentoring for GRPT members, and may have direct reports and contribute to performance management for other RA team members. Influence the development of regulations and guidance; analyze legislation, regulations, and guidance and provide analysis to the organization. Follow company policies and procedures for regulatory record‑keeping and may identify need for and develop policies and procedures within the RA department. Ensure alignment of global regulatory strategies with senior management and present regulatory assessments and recommendations to executive management. Keep supervisor informed on project resourcing, including headcount‑related fees, filing fees, and professional services. Qualifications Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject. Advanced degree or certification is preferred. Experience: 7+ years regulatory experience with at least 5+ years in a strategic leadership role and strong project management skills; drug development experience in US & Canada; experience in a complex matrix environment with multiple stakeholders and influencing cross‑functional teams; experience interfacing with major government regulatory agencies. Effective communication and negotiation skills; experience developing and implementing successful global regulatory strategies. Preferred: 10+ years’ experience in pharmaceutical regulatory activities, including leading regulatory product strategy in two or more major regions besides the US (e.g., EU or Japan); strong global drug development foundation with business acumen. Note: Higher education may compensate for years of experience. Compensation & Benefits The compensation range described below is the range of possible base pay compensation for this role. Actual compensation will depend on many factors including geographic location and may be modified in the future. This role includes a comprehensive package of benefits: paid time off (vacation, holidays, sick), medical, dental, vision insurance, 401(k) to eligible employees, and eligibility for long‑term incentive programs. Equal Opportunity Employer AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. We provide equal employment opportunities to all qualified applicants regardless of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, or gender identity. US & Puerto Rico applicants seeking a reasonable accommodation, please let us know. For additional information or to submit a request for a reasonable accommodation, visit: #J-18808-Ljbffr