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 including immunology, oncology, and neuroscience – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit Job Description 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). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. 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. Manages compounds through all phases of development, including post‑approval and throughout the life cycle of the product. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of reg strategies. Responsibilities Interface with the LRST and AST to lead and support cross‑functional company objectives. Lead the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products. Seek expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel when necessary. 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. Lead preparation of global regulatory product strategies for assigned products. Proactively lead regulatory and cross‑functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicate plan to relevant stakeholders. Act independently under the direction of a GRS Senior GRL or TA Head; may participate in or lead regulatory and company initiatives. Based on experience and scientific strengths, expand knowledge of TA and provide coaching and mentoring for GRPT members. 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 with worldwide accountability for assigned products. Follow company policies and procedures for regulatory record keeping and may identify need for and develop and implement policies and procedures within the RA department; if applicable, ensure direct reports follow requirements. Ensure alignment of global regulatory strategies with Sr. Management. Under minimal guidance of supervisor, present meaningful regulatory assessments and regulatory recommendations to executive management. Proactively inform AST and cross‑functional management, including RDLT and Commercial Leadership, of issues, labeling outcomes, approval or other risks and mitigations. Provide assessment of impact on global programs. Represent ABBV regulatory position in interactions at Joint Governance. Make decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management. Advance the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects. Follow budget allocations and keep supervisor informed on project resourcing (headcount‑related fees, filing fees, and professional services). Chair or sponsor key GRS initiatives and present outcomes to RA LT. Qualifications Required Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject. Preferred Education: Relevant advanced degree is preferred. Certification a plus. Required Experience: 7+ years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development experience in US & Canada region. Proven 5+ years in a strategic leadership role with strong project management skills. Experience working in a complex and matrix environment with multiple stakeholders and influencing cross‑functional teams. Experience interfacing with major government regulatory agencies. Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies. Preferred Experience: 10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan. Strong global drug development foundation with business acumen. Note: Higher education may compensate for years of experience. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick leave), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long‑term incentive programs. Note: No amount of pay is considered wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 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. US & Puerto Rico only – to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr