Regulatory Affairs Manager

What Regulatory Affairs contributes to Cardinal Health
Regulatory Affairs plans, coordinates and implements regulatory strategies for products that require government approval. This job family proactively identifies regulatory requirements and risks for products and develops plans for product development programs and regulatory submissions.

The Regulatory Affairs Manager will be responsible for planning, coordinating, and implementing end-to-end regulatory strategies for new products and changes, requiring prior registration/notification activities, to ensure continued global regulatory compliance of CAH brand products in the market. In addition to successful execution of regulatory strategy to ensure business continuity, this role is critical to effective resource management and driving resolution on product issues that can have significant impact on business profit/loss including but not limited to field actions/recalls.

This position is 100% remote within the US.

Responsibilities:

• Provide support for product development teams
• Observe and monitor all change regulations and act as liaison to cross functional partners
• Leading team members and overseeing submission activity
• Create and execute site and audit report
• Develop an effective regulatory strategy to accelerate time to market for design and manufacturing changes
• Drive effective execution of regulatory strategy, through clear & consistent assessment of regulatory requirements, that support product launches and/or enhancements.
• Manages department operations and supervises professional employees and/or business support staff.
• Ensure employees operate within guidelines.
• Drive efficiency and innovation within regulatory processes to ensure accurate, timely and adequate regulatory support.
• Responsible for developing and retaining talent.

• Communicating with internal parties, including but not limited to R&D, Quality, and Manufacturing teams, to provide necessary regulatory guidance and support on various business initiatives, and external parties include regulatory authorities, for example, FDA, Notified Body, etc.
• Travel up to 15%

Qualifications:

• Bachelors in related field, or equivalent work experience, preferred
• 8+ years experience in field related to Regulatory, R&D, Quality, Clinical, Medical Affairs, preferred

What is expected of you and others at this level

• Manages department operations and supervises professional employees and/or business support staff
• Participates in the development of policies and procedures to achieve specific goals
• Ensure employees operate within guidelines
• Decisions have a short-term impact on work processes, outcomes, and customers
• Interacts with subordinates, peers, customers, and suppliers at various management levels
• Interactions normally involve resolution of issues related to operations and/or projects
• Gains consensus from various parties involved

Anticipated salary range:$105,100 - $157,605

Bonus eligible:Yes

Benefits:Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close:10/10/2025 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidates geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.