Regulatory Affairs Manager coordinating regulatory submissions and compliance for Patient Assistance Programs in Brazil. Collaborating with stakeholders on program execution while ensuring ethical standards.
About the role
- Regulatory Compliance Senior Analyst at Illumina supporting compliance auditing and monitoring activities. Collaborating across functions to meet global requirements and uphold ethical standards.
Responsibilities
- Support the planning and coordination of internal audits across functions and regions.
- Assist in developing audit schedules, scoping documentation, and test plans.
- Conduct interviews, gather evidence, and prepare workpapers to support audit conclusions.
- Evaluate audit findings, document observations, and assist in tracking corrective and preventive actions (CAPAs) through closure.
- Maintain organized audit records and ensure timely follow-up with stakeholders.
- Support the implementation and maintenance of Illumina’s Regulatory Compliance Program.
- Assist in monitoring compliance metrics, reporting results, and identifying trends or recurring issues.
- Contribute to updates of policies, procedures, and work instructions to ensure alignment with current regulatory standards.
- Maintain audit and inspection readiness documentation, ensuring accuracy and accessibility.
- Support response preparation, document retrieval, and inspection logistics.
- Prepare and maintain compliance dashboards, reports, and summaries for management review.
Requirements
- Bachelor’s degree in Life Sciences, Chemistry, Regulatory Affairs, or a related discipline.
- Minimum of 5 years of experience in regulatory compliance, quality assurance, or internal audit in the biotechnology, pharmaceutical, or medical device industry.
- Working knowledge of global regulatory standards such as FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and GxP.
- Experience supporting internal or external audits, inspections, or compliance monitoring activities.
- Strong organizational, communication, and documentation skills.
Benefits
- access to genomics sequencing
- family planning
- health/dental/vision
- retirement benefits
- paid time off
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