What Regulatory Affairs contributes to Cardinal Health

The Manager, Regulatory Affairs LATAM 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 accross the Region and provides insights to senior leadership regarding regulatory developments. The Manager will lead a team of 6 specialists supporting various countries and markets.

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 within medical device organization

• 5+ years leadership experience

• Bachelor’s degree in pharmacology or related field

• English: Advance/Fluent

• Influential and inclusive leader with solid ability to mentor and lead a team located in different countries.

• Ability to build regulatory relationships across the Region.

• Previous experience leading a LATAM focused group (Brazil, Mexico, Southern Cone) is highly preferred.

• Proven experience working in a matrix environment and/or multinational companies 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

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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