Regulatory Affairs Associate (Brazil)

Contract: 12 months 

Location: Sao Paulo, Brazil (hybrid)

We are seeking a proactive Regulatory Affairs Specialist to ensure accurate and timely submission, approval, and renewal of market licenses—including new registrations, changes, and establishment licenses. You will expertly balance multiple projects and play a key role in supporting regulatory compliance and business objectives.

Key Responsibilities:

• Develop regulatory strategies and execute submissions for new registrations, changes, renewals, and establishment licenses

• Organize and manage documentation for registration dossiers

• Prepare stakeholder communications, labels, Instructions for Use, and system updates post-approval

• Support regional teams with submission schedules, prioritization, and pipeline management

• Assist in internal and external audits by providing relevant documentation

• Act as a point of contact for business and regulatory stakeholders, including government agencies

• Review label compliance in internal systems

• Represent country/subject areas in projects

• Develop operational procedures for the area

• Organize team meetings, manage agendas, and record minutes

• Manage quality issues and compulsory certification (INMETRO) and GMP activities

Competencies:

• Strong knowledge of local and international regulations

• Analytical and investigative skills

• Self-motivated, team-oriented, and strong communicator

• Excellent planning and organizational abilities

• Project management skills and proficiency in complex data handling (Excel preferred)

• Commitment to compliance and deadlines

Qualifications:

• Minimum 1–2 years’ experience in a regulatory environment, preparing submissions for Brazilian Health Authorities

• Successful track record in regulatory affairs

• Experience in medical devices or pharmaceutical companies preferred

• Bachelor’s degree in Engineering, Pharmacy, or Life Sciences (or relevant experience/training)

• Advanced reading and writing skills in English; intermediate to advanced spoken English

• Fluent in Portuguese