• Serve as Global Regulatory Strategy Leader (GRL) for late and early stage chimeric antigen receptor T cell therapy (CAR T) products for multiple hematologic malignancies. • Represent regulatory in Project Team and senior management discussions and present issues accordingly.• Develop and create global regulatory strategy for long-term planning at a cross functional level for each product, consistent with the corporate and Project Team objectives.• Interface with regional leads regarding regulatory strategy and implementation plans & provide strategic direction to ensure consistency across regions.• Engage with Regulatory Agency(ies) on project related interactions.• Identify issues proactively (i.e. regulatory or competitive) that will impact programs and provide strategies to address them. Communicate these issues to the Project Team, global regulatory sub-team, and to functional management.• Provides insight and recommendations on health authority guidance in collaboration with the strategic liaison, policy, and regulatory intelligence group.

• Serve as Global Regulatory Lead (GRL) on the Project Team for 3 investigational and 1 marketed product under the inflammation, cardiovascular, and/or oncology therapeutic areas. • Responsible for preparing, contributing to, and/or reviewing technically complex regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational products in line with ICH requirements, regional requirements, and company policies and procedures. • Develops and implements global regulatory strategy and manages complex negotiations with Regulatory Authorities.• Serve as point of contact as well as lead and coordinate formal meetings with the Food & Drug Administration (FDA). • Maintains up to date knowledge of FDA, EMA, ICH, and other regional regulatory requirements, as well as competitive intelligence, and communicate this information and their impact to Project Teams and senior management in a timely manner. • Initiates and/or contributes to local or global process improvements, which have a significant impact for the Regulatory Affairs Department. • Manages 2-3 Regulatory Affairs Associates/Mangers and oversees their respective product portfolios.

• Interact with pharmaceutical industry and academic institutions to ensure compliance with the Code of Federal Regulations (CFR) and the timely completion of reviews within the CDER/Office of New Drugs/Division of Cardiovascular and Renal Products.• Advise the industry on regulatory strategy and drug development• Serve as the co-leader of FDA Investigational New Drug (IND) and New Drug Application (NDA) review teams (scientific, regulatory, and management) to develop project plans, including setting time frames, milestones, and managing the progress of each discipline review.• Mentor new Consumer Safety Officers in the Division by setting up training plans, helping manage their workload, and serving as a subject matter expert on the CFR and Agency policy and processes.• Liaise with the European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA) to facilitate the discussion of current simultaneous reviews of new drugs in cardiovascular medicine, safety related issues that impact public health in both regions, and new regulations or processes that have implications on our daily work.• Serve as Acting Chief Regulatory Project Manager for the Division when scheduling necessitates. Responsibilities include managing six other Consumer Safety Officers, responding to emergency IND requests, workload allocation, and serving as regulatory expert in the Division.• Ensure all regulatory goals in my assigned drug group are reached in a timely manner by resolving any conflicts that may arise during the review. If a variance from the project plan occurs, I assess the impact the variance would have on the established project goals. If needed, identify and resolve resource needs or conflicts, availability and scheduling.

• Analyze and investigate the cause of any adverse drug reactions possibly related to pre or post-marketed compounds• Coordinate and author safety documents, such as Periodic Safety Update Reports (PSURs) and Annual Safety Reports (ASRs) for the European Medicines Agency (EMA) as well as IND Annual Reports (AR) and NDA Periodic Reports (PR) for the FDA which clearly summarizes a drug’s risks and benefits.

• Lead data management of Central Nervous System international Phase III clinical trial.• Present at Investigator Meetings to both investigators and monitors for Phase I & III domestic and international trials.