Evaluates the regulatory classification and feasibility of new high-complexity projects related to drug registration by consulting the current regulatory framework, relevant regulatory authorities, and historical precedents, aiming to ensure process compliance;
Prepares, submits, and monitors dossiers for submission to Anvisa and/or other regulatory bodies by applying regulatory requirements and responding to inquiries, with the aim of obtaining approval;
Provides regulatory support for products under their responsibility, including assistance in obtaining and maintaining the company's legal documentation and handling broad regulatory matters by collecting and/or sharing information on applicable regulations, with the goal of identifying and mitigating risks, facilitating internal alignment, and keeping information up to date;
Participates in meetings for technical discussions on regulatory interfaces by identifying and addressing regulatory impacts and risks to the organization, supporting decision-making that favors internal management of potential regulatory changes.

Bachelor's degree in Pharmacy;
Experience in Regulatory Affairs, preferably in Registration;
Experience with new and innovative products;
Intermediate to advanced English;
Experience with biological products;
Experience in registration and post-registration activities for cosmetics, food, and health products;
Intermediate Spanish.

Medical and dental insurance
Aché and Biosintética medications provided at no cost to you and your direct dependents
Preventive exams with no co-payment
On-site consultations and sample collection*
Wellhub (formerly Gympass)
"Estar Bem Aché" is our integrated health program, designed to care for employees' and their legal dependents' mental, physical, social, financial, occupational, and intellectual well-being
Support programs for pregnant and postpartum employees and their spouses
Partnerships and agreements offering scholarships and educational discounts at various institutions
Profit Sharing Program (PPR)
Private pension plan (1:1 contribution matching)
On-site cafeteria and meal allowance
Transportation allowance, parking, or company shuttle*
Childcare subsidy or exclusive daycare at the Guarulhos facility
Short Friday at the Guarulhos site for administrative positions
Christmas gift

Senior Regulatory Affairs Analyst – Registration Focus

About this role