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Regulatory Affairs Specialist
2 semanas atrás
As a Regulatory Affairs Specialist, you will be responsible for ensuring the maintenance and registration of products in Brazil, with a focus on keeping all products available for sale while respecting legislation, global and local policies, and company strategic planning and deadlines.
You will independently perform regulatory activities related to less complex submissions, such as package insert and label updates, register renewal, and minor variations. This includes requesting applicable documents, reviewing and evaluating documentation provided, translating applicable documents if needed, and preparing the dossier in accordance with Brazilian regulation and company SOP/policies.
With guidance and supervision from your immediate supervisor, you will also perform regulatory activities related to intermediate and greater complexity submissions, including register of new products, moderate and major variations, initial request/renewal of Good Manufacturing Practice certificate.
Key responsibilities include proposing solutions and strategies related to less complex submissions, elaborating package insert text, reviewing/approving final artwork of package inserts and labels, checking their quality, legal consistency, and compliance with regulation.
Required Skills and Qualifications:- Higher education in health, specifically Pharmacy-Biochemistry, Biomedicine, Biology
- Advanced/Fluent English (minimum reading and writing)
- Knowledge in Medical Device regulatory regulation and Medicines regulatory regulation
- Experience as Regulatory Affairs Analyst
- Experience at Medical Devices
No travel required
Others:Full-time schedule
Job Level Code: IC
Equal Employment Opportunity
