Director, Oncology Business Development and Global Regulatory Strategy

Company Description

Abb Vie’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 – immunology, oncology, neuroscience, and eye care – and offer products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

The Director, Oncology Business Development and 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. He or she leads the Global Regulatory Product Team (GRPT), continually expands therapeutic area knowledge, ensures strategic messaging and content of global regulatory dossiers, and may lead the Labeling Regulatory Strategy Team (LRST).

The Director serves as the primary regulatory interface with AST and supporting teams, proactively anticipates and mitigates regulatory risks, ensures compliance with global regulatory requirements, and manages compounds through all phases of development, including post‑approval and throughout the life cycle of the product. In addition, the Director develops and implements acceleration strategies, manages projects and necessary documentation of regulatory strategies, and demonstrates excellent understanding of drug development and leadership behaviors consistent with the level.

• Interfaces with the LRST and AST to lead and support cross‑functional company objectives and leads the GRPT to develop creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products.
• 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.
• Is accountable for ensuring that corporate goals are met and serves as a key internal leader and driver of regulatory policy and strategy for assigned products.
• Leads preparation of global regulatory product strategies for assigned products and proactively leads regulatory and cross‑functional teams 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 and may participate in or lead regulatory and company initiatives; expands knowledge of therapeutic area, provides coaching and mentoring for GRPT members, and may have direct reports and contribute to 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; if applicable, ensures direct reports follow requirements.
• Ensures alignment of global regulatory strategies with Senior Management and under the minimal guidance of supervisor presents meaningful regulatory assessments and 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 and represents ABBV Regulatory position in interactions at Joint Governance.
• Makes decisions regarding work processes or operational plans and schedules to achieve program objectives established by senior management; advances 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…