This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Specialist based in Brazil.
This role offers the opportunity to support global clinical research programs by ensuring regulatory compliance, operational excellence, and high-quality service delivery.
You will manage regulatory submissions, interpret evolving requirements, and provide expert guidance to internal teams, clients, and external stakeholders.
The position combines regulatory expertise, project coordination, and strategic thinking within an international clinical research environment.
You will contribute to the successful execution of clinical trials by ensuring documentation, processes, and submissions meet industry standards.
This role is ideal for a regulatory professional who enjoys collaboration, continuous learning, and solving complex compliance challenges.
You will have the opportunity to influence regulatory strategies while supporting impactful healthcare and research initiatives.
Accountabilities:
As a Regulatory Affairs Specialist, you will be responsible for managing regulatory activities across clinical research projects, ensuring compliance with global standards while supporting stakeholders with regulatory expertise and guidance.
- Coordinate daily regulatory affairs activities, including preparation, review, and delivery of regulatory filings, submissions, revisions, and related documentation.
- Manage clinical trial applications submitted to Competent Authorities, Ethics Committees, and regulatory agencies.
- Research, interpret, and communicate changes in global regulatory requirements, guidelines, and industry best practices.
- Develop regulatory tools, training materials, stakeholder resources, and risk assessment documentation to support project teams.
- Provide regulatory, ethics, and pharmacovigilance guidance to internal teams, sponsors, researchers, and external partners.
- Represent regulatory affairs in project meetings, audits, reviews, and discussions with clients and regulatory authorities.
- Support regulatory strategy development by identifying compliance risks and recommending solutions aligned with evolving requirements.
- Ensure clinical trial documentation, project files, and regulatory records are maintained, updated, archived, and managed according to applicable standards.
- Respond to registration requests and assist project teams in identifying regulatory requirements throughout the project lifecycle.
- Provide coaching and knowledge sharing to peers when needed and contribute to continuous improvement initiatives.
Requirements:
The ideal candidate has experience in clinical research and regulatory affairs, with strong knowledge of regional regulations and the ability to collaborate effectively with diverse stakeholders.
- Bachelor’s degree or higher in a relevant field.
- 4–6 years of experience in Clinical Research and/or Regulatory Affairs.
- Strong understanding of LATAM clinical trial regulations and regulatory submission processes.
- Experience managing regulatory documentation, submissions, and compliance activities.
- Ability to analyze regulatory requirements and translate them into practical project guidance.
- Strong organizational skills with the ability to manage multiple priorities and deadlines.
- Excellent communication and stakeholder management skills.
- Fluency in English and Spanish, both written and verbal.
- Ability to work independently in a home-based environment while collaborating effectively with global teams.
Benefits:
- Remote, home-based work environment.
- Opportunity to contribute to international clinical research projects.
- Exposure to global regulatory frameworks and industry best practices.
- Collaboration with multidisciplinary teams and external stakeholders.
- Professional growth opportunities within a regulatory-focused environment.
- Opportunity to develop expertise in evolving clinical research regulations and compliance strategies.
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