About the job
As the Director of Regulatory Affairs and Global Regulatory Lead (GRL I) at AbbVie, you will play a pivotal role in formulating and executing global regulatory strategies to obtain and sustain market approval for our products within designated therapeutic areas. You will lead the Global Regulatory Product Team (GRPT) and assume the Area Lead role for the US and Canada. Additionally, you may guide the Labeling Regulatory Strategy Team (LRST) and ensure that our global regulatory submissions and responses effectively convey our strategic messaging, while maintaining compliance with international regulations. Your responsibilities will encompass managing products throughout their development phases, including post-approval and lifecycle management.
Key Responsibilities:
- Collaborate with LRST and AST to align cross-functional corporate objectives. Lead GRPT in developing innovative global strategies that comply with regulations to meet business goals for both developmental and marketed products.
- Direct regulatory professionals and stakeholders to ensure clear and strategic messaging is incorporated into global regulatory submissions and responses to agency inquiries.
- Oversee achievement of corporate objectives, acting as a central leader and advocate for regulatory policy and strategy for assigned products, with support from management.
- Contribute to regulatory initiatives and influence regulatory frameworks by analyzing legislation and providing insightful assessments to the organization, holding global accountability for assigned products.
- Adhere to corporate policies regarding regulatory documentation, and develop internal policies within the Regulatory Affairs department as needed.
- Communicate effectively with senior management on regulatory assessments and recommendations, proactively addressing issues and risks.
