Director, RA Global Regulatory Strategy

Role Summary

The Director, Regulatory Affairs Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the Oncology therapeutic area. Leads the Global Regulatory Product Team (GRPT). 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. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product.

Responsibilities

• 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‚Äôs 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.

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. 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.
• Required Experience cont'd: Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies.
• Preferred Experience: 10+ years‚Äô 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.