Director, Oncology Business Development and Global Regulatory Strategy

Summary

Join AbbVie as the Director, Oncology Business Development and Global Regulatory Strategy, where you will be responsible for developing and implementing global strategies to secure and maintain market approval for oncology products. You will lead the Global Regulatory Product Team (GRPT), expand your therapeutic area knowledge, and ensure strategic messaging in global regulatory dossiers. You will also serve as the primary regulatory interface with AbbVie's Scientific and Technical (AST) teams, proactively anticipate and mitigate regulatory risks, and ensure compliance with global regulatory requirements. This role involves managing compounds through all phases of development, including post-approval and throughout the product lifecycle, and demonstrating a strong understanding of drug development and leadership behaviors. You will develop and implement acceleration strategies, manage projects and regulatory strategy documentation, and interface with cross-functional stakeholders to achieve business objectives. You will also lead the GRPT in developing creative global strategies aligned with applicable regulations, seek expert advice when necessary, and ensure the inclusion of clear strategic messaging in global regulatory dossiers. As a key internal leader, you will drive regulatory policy and strategy for assigned products, prepare global regulatory product strategies, and proactively lead regulatory and cross-functional teams in risk assessment and mitigation strategy development. You will act independently under the direction of a senior regulatory leader, participate in or lead regulatory and company initiatives, expand your therapeutic area knowledge, and provide coaching and mentoring for GRPT members. You may also have direct reports and contribute to the performance management of other regulatory affairs team members. You will influence the development of regulations and guidance, analyze legislation, regulations, and guidance, and provide analysis to the organization with worldwide accountability for assigned products. You will follow company policies and procedures for regulatory record keeping, identify the need for and develop and implement policies and procedures within the regulatory affairs department, and ensure direct reports follow requirements. You will ensure alignment of global regulatory strategies with senior management, present meaningful regulatory assessments and recommendations to executive management, proactively inform stakeholders of issues, labeling outcomes, approval or other risks and mitigations, and provide assessments of impact on global programs. You will represent AbbVie's regulatory position in interactions at Joint Governance, make decisions regarding work processes or operational plans and schedules, and advance the organization's goals by participating in and taking leadership roles in professional associations, industry, and trade groups. You will follow budget allocations, keep your supervisor informed on project resourcing, chair or sponsor key initiatives, and present outcomes to the regulatory affairs leadership team.

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)
• Continually expand TA knowledge, and ensure 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
• Interfaces with the LRST and AST to lead and support cross-functional company objectives
• Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products
• When necessary, seeks expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel
• Leads 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
• Leads preparation of global regulatory product strategies for assigned products
• Proactively leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicates plan to relevant stakeholders
• Acts 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, expands knowledge of TA and provides coaching and mentoring for GRPT members
• May have direct report(s) and contribute to the performance management for other RA team members
• Influences the development of regulations and guidance
• Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products
• Follows 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
• Ensures alignment of global regulatory strategies with Sr. Management
• Under minimal guidance of supervisor, presents meaningful regulatory assessments and regulatory recommendations to executive management
• Proactively informs AST and cross functional management, including RDLT and Commercial Leadership,of issues, labeling outcomes, approval or other risks and mitigations
• Provides assessment of impact on global programs
• Represents ABBV Regulatory position in interactions at Joint Governance
• Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management
• Advances the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects
• Follows budget allocations and keeps supervisor informed on project resourcing (headcount-related fees, filing fees, and professional services)
• Chairs or sponsor key GRS initiatives and presents 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