Especialista De Asuntos Regulatorios

Cardinal Health; México; In loco; MXN 250.000 - 350.000; Tempo pieno

Descrizione del lavoro

Cardinal Health seeks a junior Regulatory Affairs professional to join our team in Mexico. The role provides support across regulatory processes, submissions, data entry, and global registrations, contributing to compliant product development and lifecycle activities.

You will assist in maintaining regulatory databases, reviewing promotional materials for compliance, and supporting life cycle management under supervision, with exposure to global regulatory standards.

Competenze

• Bachelor’s degree in related field, or equivalent work experience, preferred.
• 0-2 years of experience, preferred.

Mansioni

• 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

Formazione

Bachelor’s degree in related field

Descrizione del lavoro

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

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 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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