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.
 

Responsibilities

Assist in development and/or implementation and/or maintenance of regulatory processes & procedures, systems, databases and reporting mechanisms/tools to ensure they are in compliance with global regulations/guidance’s/ standards and in alignment with overall business strategic goals and prioritiesAssist in technical review of data or reports in support of product life cycle management and regulatory submissionsAssist in preparation and maintenance of global product registrationsData entry, remediation, and maintenance of various regulatory databasesAssist in review of product promotional materials, labeling, specification sheets, or test methods for compliance with applicable regulations, market approvals and policies

Qualifications

0-2 years of experience, preferredBachelor's degree in related field, or equivalent work experience, preferred

What is expected of you and others at this levelApplies basic concepts, principles and technical capabilities to perform routine tasksWorks on projects of limited scope and complexityFollows established procedures to resolve readily identifiable technical problemsWorks under direct supervision and receives detailed instructionsDevelops competence by performing structured work assignments

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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