Sr Director, Regulatory Affairs

• Set and steward the U.S. regulatory vision and longrange (3-5 year) strategic roadmap for the Nutrition portfolio, establishing enterprisewide priorities, resource allocations, and investment decisions.
• Provide executive leadership for all regulatory strategy, planning, and execution activities, ensuring the development, crossfunctional alignment, and successful delivery of highimpact regulatory submissions that enable market access, product launches, and hospital formulary inclusion.
• Exercise strategic governance over all regulatory documentation and compliance operations, ensuring rigorous review, approval, and lifecycle management of labeling, promotional materials, product dossiers, and registration packages across the Nutrition Business Unit.
• Define the overarching regulatory agenda for the organization, guiding the design and execution of complex, multiyear regulatory programs that require differentiated strategies, competitive positioning, and proactive risk mitigation.
• Chair the U.S. Claims & Labeling Governance Council, ensuring competitive, compliant, and scientifically defensible claims across all commercial channels.
• Serve as the senior executive liaison to FDA's Human Foods Program, leading highstakes negotiations, shaping regulatory policy positions, and influencing outcomes through industry coalitions and trade associations.
• Partner closely with Commercial and Marketing leadership to align regulatory strategy with business objectives, growth plans, and brand positioning.
• Collaborate with R&D, Medical Affairs, Legal, and Corporate Affairs to shape brand strategy, enable innovation, and ensure regulatory readiness for new product introductions.
• Architect and oversee execution of U.S. regulatory strategies that enable timely commercialization of new and innovative products.
• Evaluate regulatory requirements relative to program needs and ensure early, clear communication of expectations throughout the R&D lifecycle to support robust technical dossier development.
• Set strategic priorities for the regulatory organization, ensuring alignment of team objectives with broader business goals.
• Hold ultimate accountability for the compliance, substantiation, and governance of all promotional materials and marketing claims.
• Maintain deep awareness of the evolving regulatory landscape, translating emerging risks and opportunities into actionable guidance for internal stakeholders to ensure compliance and support successful product launches.
• Proactively monitor and assess emerging regulatory issues, developing mitigation strategies to protect business continuity and competitive advantage.
• Communicate complex scientific and regulatory concepts with clarity and authority to executive leadership, key opinion leaders, and government agencies.
• Cultivate trusted relationships with regulatory authorities, KOLs, and external stakeholders to enhance the organization's credibility and influence.
• Represent the company in scientific and trade organizations, shaping industry positions on innovation, safety, and nutrition standards through evidencebased advocacy.
• Provide leadership and oversight to regulatory managers and staff, ensuring efficient, agile workflows that adapt to evolving business priorities.
• Direct and prioritize team workload to meet departmental and enterprise objectives.
• Guide staff through shifting priorities, processes, and regulatory expectations, ensuring clarity and alignment.
• Lead the development of systems, processes, and tools that enhance operational efficiency and regulatory excellence.
• Inspire and motivate the team, maintaining focus on strategic objectives and fostering a highperformance culture.
• Collaborate with crossfunctional leaders across the organization to provide regulatory expertise and influence strategic decisions for both developmentstage and marketed nutrition products.
• Engage directly with regulatory agencies to address issues, negotiate outcomes, and advocate for the company's positions.
• Lead resolution of complex, technical regulatory matters, driving them to successful outcomes.
• Provide expert commentary on proposed regulations to influence policy direction and protect business interests.
• Communicate increasingly complex regulatory and scientific issues with clarity and conviction to internal and external stakeholders.
• Serve as a senior representative of the company to regulatory bodies, professional organizations, and strategic business partners.
• Ensure timely communication of evolving regulatory and development requirements across the organization.
• Influence and align crossfunctional peer leaders to support regulatory strategies and enterprise objectives.
• Develop talent through coaching, performance management, and structured growth opportunities; identify and address performance gaps early; promote crosstraining and stretch assignments to build organizational capability.
• Lead as a catalyst for change, constructively challenging the status quo and driving continuous improvement across the regulatory function.

Job Requirements:

• Bachelor's Degree in a scientific discipline and 15 years' experience required; advanced degree preferred.
• Minimum of 12 years' experience in Nutrition Regulatory Affairs with at least 7 years of leadership experience.
• Experience in directing a regulatory team in preparing and assessing regulatory strategy and supportive documents as well as Advertising and promotional materials.
• Previous leadership experience required, with experience in directly managing multiple levels of staff and influencing cross functional teams and stakeholders.
• Through understanding of the CFR, FDA/ICH guidelines and cGMP's.
• Effective communication and leadership skills are essential.
• A strong business orientation is considered a plus.
• Must be capable of making decisions, affecting a multitude of departments/disciplines to ensure that the company's business/budgetary objectives are met.
• The incumbent must be capable of interfacing with the Executive Group, Governmental Agencies and outside individuals on a regular basis.
• Must have a complete understanding of the nutrition and food regulatory requirements and development process.
• Must be capable of handling extremely complex facts/data and developing decisions/recommendations quickly.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.