Assistant General Counsel, Regulatory
Cardinal HealthAbout the role
What Regulatory contributes to Cardinal Health
Legal provides the company with strategic, proactive, practical and cost-effective legal advice and services in order to protect the organization's assets, operations and image. This function provides legal counsel related to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company legal matters, manages outside counsel and manages legal operations.
Regulatory provides legal-regulatory counsel and advice to businesses concerning regulatory actions and issues, both proactively and reactively. This job family reviews and advises the organization's response to alleged regulatory actions and violations and represents the organization in such matters before regulatory bodies.
Job Summary
The Assistant General Counsel, Regulatory will be responsible for advising on matters pertaining to laws governing per- and polyfluoroalkyl substances (PFAS); other ingredient, additive, and chemical-focused regulation; extended producer responsibility (EPR) regulations; and other product-specific environmental / sustainability drug and device lifecycle obligations and stewardship programs. This role will also advise on issues pertaining to the Environmental Protection Agency (EPA), OSHA (Occupational Safety and Health Administration), and similar agencies at the federal, state and local levels. As described in more detail below, regulatory legal also reviews and advises on regulatory agency inquires and alleged violations and may represent Cardinal Health in such matters before regulatory bodies.
Responsibilities
• Analyze and advise on US federal environmental, health and safety legal matters, with particular emphasis on OSHA and EPA. This entails working closely with and supporting the internal EHS function at Cardinal Health.
• Analyze and advise on US state and federal laws and regulations impacting products and services offered by Cardinal Health businesses, for example, PFAS-focused legislation and regulation, chemical and color additive legislation and regulations, and EPR and other drug and device stewardship programs. This entails working with multiple business leaders across the enterprise.
• Partner with and advise Government Relations teams regarding the impact of newly introduced and/or enacted US federal and state laws, regulation, and government policy in the environmental space.
• Draft and advise on communications with regulatory agencies (e.g., requests for additional information, allegations of violations, inspection report responses, disciplinary matters).
• Identify opportunities for process improvements and efficiencies and work with various functional areas to help reduce potential regulatory exposure and to strengthen and improve systems and processes.
• Anticipate and advise on emerging regulatory trends.
• Educate and train on regulatory requirements.
• Develop deep knowledge and understanding of the company and its businesses; demonstrate business acumen.
• Identify legal and compliance issues and risks, and escalate appropriately, exercising sound judgment about matters that require attention of senior leadership.
• Advise and collaborate with subject matter experts from other functions and teams and delegate and direct non-legal tasks to support regulatory compliance implementation.
Qualifications
• Bachelor and JD degrees required
• 12+ years experience in administrative law focused on environmental matters (e.g., sustainability, health, safety, product-focused environmental/sustainability regulation) preferred
• Experience in private practice strongly preferred
• Familiarly with medical device and pharmaceutical regulation
• Active license in good standing to practice law in the state of residence
• Excellent oral and written communication skills
• Acute attention to detail and deadlines
• Excellent interpersonal skills and the ability to interface effectively and cultivate trust and confidence with clients at different levels throughout the company, as well as with regulatory bodies
• Enthusiasm and "self-starter" qualities enabling individual to work independently and manage responsibilities with an appropriate sense of urgency and responsiveness
• The ability to function effectively and efficiently in a highly matrixed environment with multiple and differing business units, product portfolios and supply chains
• The ability to advise and collaborate with subject matter experts from other functions and teams and delegate and direct non-legal tasks to support regulatory compliance implementation
What is expected of you and others at this level
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