Director, RA Global Regulatory Strategy

AbbVie • Irvine, IL

2d

About The Position

The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, develops and implements global regulatory strategies to secure and maintain market approval for products in the assigned therapeutic area. The role leads the Global Regulatory Product Team (GRPT), may lead the Labeling Regulatory Strategy Team (LRST), and serves as the primary regulatory interface with the AST and supporting teams. The Director proactively anticipates and mitigates regulatory risks, ensures compliance with global regulatory requirements, and manages compounds through development, post-approval, and the full product life cycle.

This position leads regulatory policy and strategy for assigned products, prepares global regulatory product strategies, and ensures strategic messaging is reflected in global regulatory dossiers and responses to agency requests. It provides regulatory assessments and recommendations to executive management, communicates issues and risks to cross-functional and commercial leaders, and represents AbbVie’s regulatory position in joint governance. The role may mentor team members, manage direct reports, lead initiatives, and influence regulations and guidance. It acts independently under the direction of a GRS Senior GRL or TA Head.

Requirements

• Bachelor’s degree in life sciences, such as pharmacy, biology, chemistry, or pharmacology, or a related subject.
• At least 7 years of regulatory experience; some experience may be from another R&D role or specialized training related to pharmaceutical regulatory work.
• Drug development experience in the US&C region.
• At least 5 years in a strategic leadership role, with strong project management skills.
• Experience working in a complex, 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.

Nice To Haves

• Relevant advanced degree; certification is a plus.
• At least 10 years of experience in pharmaceutical regulatory activities.
• Experience as lead regulatory product strategist in two or more major regions in addition to the US, such as the EU or Japan.
• Strong global drug development foundation and business acumen.

Responsibilities

• Lead the GRPT in developing creative global regulatory strategies aligned with applicable regulations and business objectives for development and marketed products.
• Interface with the LRST and AST to lead and support cross-functional company objectives.
• Lead cross-functional stakeholders and regulatory professionals in developing clear strategic messaging for global regulatory dossiers and responses to regulatory agency requests.
• Prepare global regulatory product strategies for assigned products and ensure alignment with senior management.
• Lead the preparation and maintenance of risk assessments and mitigation strategies, and communicate plans to relevant stakeholders.
• Proactively inform AST and cross-functional management, including RDLT and Commercial Leadership, about issues, labeling outcomes, approval risks, and mitigations; assess impacts on global programs.
• Present regulatory assessments and recommendations to executive management and represent AbbVie’s regulatory position in joint governance.
• Analyze legislation, regulations, and guidance and provide assessments to the organization; contribute to the development of regulations and guidance.
• Manage regulatory records and follow company policies and procedures; as applicable, identify, develop, and implement RA policies and procedures and ensure direct reports follow requirements.
• Coach and mentor GRPT members and, where applicable, contribute to performance management for RA team members.
• Participate in or lead regulatory and company initiatives; chair or sponsor key GRS initiatives and present outcomes to the RA Leadership Team.
• Make decisions about work processes, operational plans, and schedules to achieve program objectives established by senior management.
• Advance organizational goals through leadership roles in relevant professional associations, industry groups, and trade groups.
• Follow budget allocations and keep the supervisor informed about project resourcing, including headcount-related fees, filing fees, and professional services.
• Develop and implement acceleration strategies and manage project documentation for regulatory strategies.

Benefits

• Paid time off, including vacation, holidays, and sick time.
• Medical, dental, and vision insurance.
• 401(k).
• Eligibility to participate in long-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Director