International Regulatory Affairs Manager

What Regulatory Affairs contributes to Cardinal Health

Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting.

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.

Job Summary

The Manager, Regulatory Affairs directs regulatory affairs activities, so the organization has the permits, licenses, certificates, authorizations, and other approvals it needs to conduct its current and future business activities. The Manager liaises with managers of other functions to understand their business goals and assesses necessary approvals and related processes to enable those goals. This job also maintains relationships with regulatory authorities and provides insights to senior leadership regarding regulatory developments. The Manager leads a team of Specialists and manages the operations of the Regulatory Affairs department.

Responsibilities

• Leads a team of Regulatory Specialists. Delegates projects and specific work tasks, reviewing the work of others and providing specific direction to less experienced Specialists. Conducts performance evaluations for team members and makes recommendations to the Director regarding talent management and compensation.

• Directs the preparation of regulatory submissions, annual renewals, and notifications of product changes. In managing a large number of applications, creates comprehensive schedules to track completion of applications, monitors the success and failure of submissions, and reports progress to the Director.

• Establishes and maintains positive relationships with government agencies and other regulatory authorities. Represents the organization in matters before regulatory, legislative, or industry standards agencies to advance the organization's interests.

• Liaises with managers of other functions to understand their business goals, such as introducing a new product or service or entering a new market. Identifies pertinent approvals and regulatory considerations and sets timelines for submitting applications.

• Manages the preparation of the most difficult, complex, or large application processes so they are likely to be successful. Provides guidance to team members in responding to additional questions and requests from regulators in responses to submitted applications.

• Provides guidance to internal stakeholders regarding regulatory requirements and the collection and maintenance of information relevant to the submissions. Explains Regulatory Affairs implications and impacts of operational and product changes, leveraging insights from Specialists.

• Updates and creates new standard operating procedures in response to regulatory developments or significant changes in the organization’s products and operations, so that regulatory submissions and renewals can be completed efficiently and with minimal error.

• Collaborates with legal counsel for the review of legal terms and in the preparation of complex submissions and renewals. Hires and manages relationships with external consultants as necessary to assist with submissions.

• Provides insights to senior leadership as a subject matter expert regarding regulatory developments and their potential impacts on the organization’s operations, such that leadership can integrate these insights into short- and long-term strategies.

Qualifications

• 8-12 years of experience, preferred

• Bachelor’s degree in related field, or equivalent work experience, preferred

What is expected of you and others at this level

• Manages department operations and supervises professional employees, front line supervisors and/or business support staff

• Participates in the development of policies and procedures to achieve specific goals

• Ensures 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; may interact with senior management

• Interactions normally involve resolution of issues related to operations and/or projects

• Gains consensus from various parties involved

Anticipated salary range: $103,500 - $155,295

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: 5/16/2025 *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 candidate’s 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.

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