Job Description

The Director Regulatory Affairs Global Regulatory Lead in Global Regulatory Strategy is responsible for developing and implementing global  regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role.  May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams.  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 strong understanding of drug development and leadership behaviors consistent with level.   Develops and implements acceleration strategies with guidance from supervisor.

Responsibilities:

Interfaces with the LRST and AST to implement cross-functional company objectives.  Under supervision, leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed product.  Proactively seeks expert advice and technical support from cross 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. With support from manager, acts as key internal leader and driver of regulatory policy and strategy for assigned products. Leads preparation and maintenance of global regulatory product strategies for assigned products. Under guidance of supervisor, 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

May participate in regulatory and Company initiatives.

May influence 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 develop and implement policies and procedures within the RA department.

Under guidance from supervisor, ensures alignment of global regulatory strategies with Sr. Management Under direction of supervisor, presents meaningful regulatory assessments and regulatory recommendations to executive management with. Proactively informs AST and management of issues, risks and mitigations.  Provides assessment of impact on global programs. Provides informed regulatory opinion based on experience and expertise.

Under direction from supervisor, 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.