Sao Paulo, BRA
1 day ago
Especialista de Assuntos Regulatórios
**_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 priorities + Assist in technical review of data or reports in support of product life cycle management and regulatory submissions + Assist in preparation and maintenance of global product registrations + Data entry, remediation, and maintenance of various regulatory databases + Assist 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, preferred + Bachelor's degree in related field, or equivalent work experience, preferred **_What is expected of you and others at this level_** + Applies basic concepts, principles and technical capabilities to perform routine tasks + Works on projects of limited scope and complexity + Follows established procedures to resolve readily identifiable technical problems + Works under direct supervision and receives detailed instructions + Develops 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._ _To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
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