Regulatory Intelligence Project Manager

Profile

Regulatory Intelligence Project Manager

Responsibilities: Identify, capture and track new or changed Regulations, Standards and Guidance that affect Diabetes Care processes or products and assess their impact on the business. Research and maintain a current understanding of new / evolving Regulations, Standards and Guidance. Develop new or update existing regulatory policies, processes and SOPs and train key personnel on them. Lead cross-functional team meetings to drive the implementation of the emerging regulations process, and investigate and/or conduct Gap Assessments to determine the impact of regulatory changes on the business. Manage Regulatory tasks and deliverables under the scope of the Regulatory Intelligence process worldwide. Communicate key changes in regulations to management and affected stakeholders within the business. In conjunction with other functions, continuously improve the Regulatory Intelligence process and implement an electronic solution. Help ensure competitive position on the market through the implementation of strategic regulatory intelligence in regulatory submissions. Support the Regulatory Affairs Director in the execution of Trade Association and external Advocacy activities. Monitor trade association positions for impact on company products. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and cross-functional teams. Recruit, develop and mentor regulatory professionals. Assist in regulatory due diligence for potential and new acquisitions. Utilize technical regulatory skills to propose strategies on complex issues. Apply Lean principles to help improve processes and manage follow-up actions until completion. Track and trend key performance indicators (KPIs). Participate in projects, as assigned, to address changes in the Regulatory landscape. Exercise independent judgment and have past experience in leading cross-functional teams to meet regulatory requirements and project objectives within due dates. Effectively interpret and apply regulatory requirements. Be recognized as a discipline expert and resource in regulatory affairs. Develop, communicate, and build consensus for operating goals that are in alignment with the division. Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. Apply Project Management skills and lean principles to create immediate to long-range plans, identify key milestones and KPIs, forecast resources and capital expenditures, and implement projects to meet goals and objectives.

Additional Information

Ref.30956534

Company info

Abbott
1360 South Loop Road
Alameda
California
United States 94502
Website : http://www.abbott.com