Director, RA Global Regulatory Strategy

Director, Regulatory Affairs 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 products in the obesity / metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT) and Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Continuously expands TA knowledge in obesity and ensures strategic messaging and content of global regulatory dossiers. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds in the obesity TA through all phases of development, including post approval and through the life cycle of the product. Demonstrates excellent understanding of drug development in the obesity / metabolic TA and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of regulatory strategies.

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.
• 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.
• 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.
• 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.
• 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.

This is a hybrid onsite opportunity. The role has flexibility to be based in AbbVie's Lake County, IL or Florham Park, NJ offices.

Qualifications :

Note : Higher education may compensate for years of experience.

Additional Information :

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

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

This job is eligible to participate in our short-term incentive programs.

This job is eligible to participate in our long-term incentive programs.

Salary : $177,000 - $336,000