Director, Regulatory Strategic Program

The Opportunity

This position works out of our Abbot Park, IL location in the AQR Abbott Quality and Regulatory division.

The GSR VISION is to positively shape the global regulatory landscape through innovation, collaboration, and advocacy. The GSR MISSION is to leverage the leadership and expertise of Regulatory Affairs to help Abbott deliver life-changing technology to people around the world.

GSR provides support to all Abbott businesses across the globe. Through a culture of collaboration, GSR facilitates knowledge sharing and aims to deliver One Abbott voice.

The Director, Regulatory Strategic Program will manage a Program Management Office that reports up through Government and Regulation team to the Sustainability 2030 Plan, priorities, and efforts ().

Sustainability is implicit in Abbott’s purpose : helping people live fuller lives. That commitment begins with the healthcare products and technologies we create and carries through everything we do as a company.

What You’ll Work On

• Provide strategic regulatory guidance in the development of long-term and annual plans for US and key global, established and emerging markets across relevant businesses of Abbott
• Manage execution of projects in accordance with recognized project management methodologies such as PMBOK.
• Develop, prioritize and submit project plans, budgets and methodologies across a range of key projects.
• Define project resources, performance reviews and post implementation evaluations.
• Responsible for the successful implementation of a set of projects that collectively comprise a program.
• Engage stakeholders within Abbott at multiple levels and externally including external Advisors and supplier financial contacts.
• Apply strategic thinking and leverage regulatory knowledge to guide the strategic plans across the business, geographies, and other Abbott programs.
• Provide input on measurements to provide meaningful progress against program objectives.
• Resolves project issues by working with team members, project customers and others as appropriate.
• Understands business environment and relates extensive knowledge of internal and external technological activities to trends.
• Plans and organizes projects of substantial variety and complexity.
• Establishes priorities and leads projects to completion.
• Moderate and facilitate group discussions and strategic planning sessions for key internal and external stakeholders.
• Erroneous decisions or recommendations would typically result in failure to achieve program and organization objectives.
• May manage the work of project managers.

Scope of Position :

• Passionate about driving change in the regulatory environment, improving regulatory agency relationships and influencing the development of regulations and guidance
• Comprehensive knowledge and experience in Global Regulatory processes and regulations
• Ability to apply Regulatory strategic thinking adapting to the needs of the business and the evolving Regulatory landscape.
• Cross divisional familiarity / Abbott experience
• Extensive experience working with cross-functional teams and multiple partners, executing strategies, delivering solutions, and leading cross-functional projects
• Outstanding leadership skills including innovative approach to problem-solving and an integrated view of regulatory and business challenges
• Collaborative leader with strategic vision and alignment with department, division and corporate objectives
• Executive presence with excellent verbal and written communication skills and demonstrated ability to clearly and concisely communicate compelling messages to a wide range of audiences, both internal and external
• Proven ability to communicate with diverse global stakeholders with cultural sensitivity.
• Ability to thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient
• Meticulous attention to detail, excellent organizational, prioritization and multi-tasking skills
• Process oriented with experience in development, implementation and management of standard regulatory policies, processes and SOP / DOPs
• Expertise in group discussion facilitation with ability to be inclusive and collaborative in achieving consensus of divergent opinions from multiple key stakeholders
• Independent and autonomous project manager with self-initiative and drive for timely completion of milestones
• Ability to develop, communicate, and build consensus for operating goals that are in alignment with the division and corporation
• Experience interfacing with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units
• Experienced talent manager with ability to recruit, develop, and mentor regulatory professionals
• Proven demonstration of ability to develop strong relationships with key regulatory agencies and other similar stakeholders
• Ability to develop, communicate, and build consensus for goals and programs that support division, business unit and company objectives
• Participation in applicable trade association and / or industry working groups to influence policy / rule-making in alignment with business strategies

Required Qualifications

• Bachelor’s degree in science (Biology, Chemistry, Microbiology, Immunology, medical technology, Pharmacy, Pharmacology)
• 10+ years of experience in a regulated industry (e.g. Medical products, nutritional)

Preferred Qualifications

• Master’s Degree in a technical area or M.B.A. is preferred.
• A Ph.D. In a technical area or law is helpful
• 10+ years of experience in a regulatory industry is preferred but may consider quality assurance, research and developmental / support, scientific affairs, operations, or related area
30+ days ago