Director, RA Global Regulatory Strategy

AbbVie'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 products and services in our Allergan Aesthetics portfolio.

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). Continually expands TA knowledge, and ensures 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.

The Scope of the Role :

• 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.
• 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.
• 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.
• Ensures alignment of global regulatory strategies with Sr. Management. Presents meaningful regulatory assessments and regulatory recommendations to executive management.
• Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management.
• Follows budget allocations and keeps supervisor informed on project resourcing.

The preference is for this role to be onsite in AbbVie’s Lake County, IL office with a hybrid schedule. However, remote work flexibility may be available for someone not located near one of our offices.

Qualifications :

We offer a comprehensive package of benefits including paid time off, medical / dental / vision insurance, and 401(k) to eligible employees.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer / Veterans / Disabled.

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