Analyst Regulatory Affairs Consultant (Pharma)

TL;DR

Analyst Regulatory Affairs Consultant (Pharma): Ensuring proper submission and approvals for market licenses and registrations with an accent on Brazilian Health Authorities compliance. Focus on executing regulatory strategies, managing registration dossiers, and coordinating with government agencies.

Location: Hybrid (Brazil)

Company

hirify.global is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Develop and execute regulatory strategies for new registrations, changes, and renewals.
• Obtain and update establishment registration licenses.
• Prepare communications for stakeholders, labels, and Instructions for Use (IFU).
• Request and track documentation to prepare registration dossiers.
• Support internal and external audits with documentation requests.
• Act as a point of contact for stakeholders to support business plans and regulatory needs.

Requirements

• 1-2 years of experience in a Regulatory Environment preparing submissions for Brazilian Health Authorities.
• Bachelor's degree in Engineering, Pharmacy, or other life sciences.
• Advanced reading and writing skills in English; intermediate to advanced speaking.
• Fluency in Portuguese.
• Knowledge of local and international regulations and processes.

Nice to have

• Experience in Medical Devices or Pharma background.
• Project management skills and proficiency in using Excel for complex data.

Culture & Benefits

• Supportive culture with a strong focus on professional development and quality.
• Opportunity to work within a global CRO with professionals across 20+ countries.
• Commitment to diversity and inclusivity.
• Access to continuous training to maintain high levels of competence and expertise.