Director, Oncology Business Development and Global Regulatory Strategy

Summary

Join AbbVie as a Director, Oncology Business Development and Global Regulatory Strategy and lead the development and implementation of global strategies to secure and maintain market approval for oncology products. You will lead the Global Regulatory Product Team (GRPT), expand therapeutic area knowledge, and ensure strategic messaging in global regulatory dossiers. This role requires proactive risk mitigation, compliance with global regulatory requirements, and management of compounds throughout their lifecycle. You will interface with cross-functional teams, influence regulatory policy, and represent AbbVie's regulatory position in various interactions. The position requires strong leadership, communication, and strategic planning skills. Location flexibility is offered.

Requirements

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject
• 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&C 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
• Strong communication and proactive negotiation skills
• Experience developing and implementing successful global regulatory strategies

Responsibilities

• Develop and implement global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area
• Lead the Global Regulatory Product Team (GRPT)
• Continuously expand TA knowledge, and ensure strategic messaging and content of global regulatory dossiers
• May lead the Labeling Regulatory Strategy Team (LRST)
• Serve as the primary regulatory interface with AST and supporting teams
• Proactively anticipate and mitigate regulatory risks
• Ensure compliance with global regulatory requirements
• Manage compounds through all phases of development, including post-approval and throughout the life cycle of the product
• Demonstrate excellent understanding of drug development and leadership behaviors consistent with level
• Develop and implement acceleration strategies
• Manage projects and necessary documentation of reg strategies
• 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
• When necessary, seek expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel
• 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
• Ensure that corporate goals are met
• Serve as a 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 Sr 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 report(s) and contribute to the 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 and, 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

Preferred Qualifications

• Relevant advanced degree is preferred
• Certification a plus
• 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

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs