Director, RA Global Regulatory Strategy

Company Description AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas—immunology, oncology, neuroscience, eye care—and in our Allergan Aesthetics portfolio. 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. This role leads the Global Regulatory Product Team (GRPT) and may serve as the primary regulatory interface with the AST and supporting teams, ensuring compliance with global regulatory requirements and managing products through all development phases. Responsibilities Interface with the Labeling Regulatory Strategy Team (LRST) and AST to implement cross‑functional company objectives. Lead the GRPT to develop global strategies in line with applicable regulations to achieve business objectives. Lead cross‑functional stakeholders and regulatory professionals to ensure clear strategic messaging in global regulatory dossiers and responses to regulatory agencies. Act as a 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 for assigned products. Participate in regulatory and company initiatives and analyze legislation, regulations and guidance to inform the organization. Develop and implement policies and procedures within the RA department and support regulatory record keeping. Present regulatory assessments and recommendations to executive management and inform AST and management of issues, risks and mitigations. Make decisions regarding work processes and operational plans to achieve program objectives. Monitor budget allocations and report on project resourcing. Qualifications Required Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject). Preferred Education: Advanced degree or relevant certification. Required Experience: 5+ years of regulatory experience, including at least 3 years in a strategic leadership role with strong project‑management skills. Experience working in a complex, matrixed environment with multiple stakeholders and interfacing with government regulatory agencies. Strong communication, negotiation, business acumen and ability to work under pressure. Preferred Experience: 7+ years in pharmaceutical regulatory activities, preferably across at least two regions or major countries; experience developing and implementing global regulatory strategies; drug‑development experience preferred. Additional Information The compensation range described below represents the range of base pay the Company believes in good faith it will pay for this role at the time of posting, based on the job grade. Actual compensation will depend on geographic location and may differ from the posted range. We offer a comprehensive benefits package that includes paid time off (vacation, holidays, sick leave), medical/dental/vision insurance and a 401(k) plan for eligible employees. Employees may be eligible to participate in short‑term incentive programs. AbbVie is an equal‑opportunity employer committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled. US & Puerto Rico only – to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr BioSpace