Role Overview and Responsabilities

We are looking for a professional to join our team as a Regulatory Affairs Coordinator in São Paulo, SP.

Key responsibilities include:

• Manage and prepare registration and post-registration submissions for synthetic medicines, food products, and medical devices by conducting regulatory assessments to maintain and expand the company’s portfolio.
• Assess the feasibility of new products (BD&L) from a regulatory perspective, ensuring appropriate classification and defining the actions required to expand the portfolio.
• Represent the company in meetings with ANVISA, local health surveillance authorities, the Regional Pharmacy Council (CRF), and related entities, supporting product registrations and business-critical projects, as well as developing proposals and assessing regulatory impacts within the legal and public health environment.
• Support the company’s regulatory intelligence activities—including legislative impact assessments, review-queue tracking, and process monitoring—to map and identify competitive advantages for the business.
• Ensure the regulatory compliance of legal documentation—including operating licenses, national and international GMP certificates (CBPF), AFE, AE, LTA, and CRF—for all Group units, maintaining their good standing with health authorities and supporting the continuity of company operations.
• Review product promotional materials in accordance with current health regulations to ensure compliance with company activities, and train marketing agencies and all employees involved in the approval workflow in line with applicable procedures and legislation.
• Review packaging materials in the designated system to ensure the regulatory compliance of products approved for sale.
• Review technical (quality) and administrative documents to ensure technical compliance with the Federal Pharmacy Council and Health Surveillance Authorities of the
• Manage the team by setting goals and objectives and providing ongoing feedback to develop each individual’s potential.

What we are looking for

• Bachelor’s degree, preferably in Pharmacy or a related healthcare field.
• Solid experience in the pharmaceutical industry, with broad regulatory affairs expertise.
• Experience in New Business / BD&L (Business Development & Licensing).
• Advanced English proficiency, essential for frequent meetings with the Global team.