Regulatory Affairs Specialist (North America, LATAM, EU)

Role summary

This position is focused on delivering global regulatory affairs support on a day-to-day basis. The role involves overseeing clinical trial submissions to Competent Authorities, Ethics Committees, and other regulatory bodies, along with researching, evaluating, and reporting on international regulations and compliance requirements. The specialist will also help build stakeholder tools, assess regulatory risks, and act as a resource for internal teams, sponsors, researchers, and external authorities. Consistently high service quality and timely delivery are expected, aligned with corporate, industry, and regulatory standards. The role may also include coaching colleagues and contributing to performance reviews.

Unit management

• Manage the daily flow of regulatory services and related processes, including preparing, compiling, and updating filings, submissions, and revisions for projects, vendors, and clinical sites.
• Support regulatory and safety review activities, develop regulatory tools and learning materials, and stay up to date on clinical research regulations and industry best practices, sharing relevant updates with project leaders promptly.

Client services

• Act as a regulatory affairs subject matter resource, offering guidance on regulatory, ethics, and pharmacovigilance matters to project stakeholders.
• Represent the unit in project discussions, support education and tool development, take part in regulatory reviews and audits, liaise with clients and regulatory or government representatives, and answer regulatory questions on behalf of the client when needed.

Regulatory strategy development

• Track changes in clinical research regulations and industry best practices, then recommend, implement, and maintain corporate regulatory strategies in collaboration with other specialists such as safety and quality assurance, so compliance keeps pace with changing requirements.
• Attend specialized conferences and meetings as required to strengthen knowledge and stay current.

Project support

• Respond regularly to registration requests and work with project teams to determine applicable regulatory requirements.
• Assist with preparing regulatory submissions and supporting summary documents.
• Make sure project and clinical site files are created, maintained, revised, archived, or destroyed according to project and regulatory rules, and ensure stakeholders are trained and informed about all applicable requirements.

Qualifications

Candidates need at least an undergraduate degree and 4 to 6 years of relevant experience in clinical research or regulatory affairs. Strong knowledge of LATAM clinical trial regulations is required, and the role also requires written and spoken fluency in both English and Spanish.

Working conditions

• This is a home-based role.
• Reasonable accommodations for applicants with disabilities are available upon request.

Additional information

The hiring process may include the use of artificial intelligence tools to help review applications, examine resumes, assess responses, and flag possible inconsistencies or verification signals using available information. These tools support the recruitment team but do not replace human judgment. Final hiring decisions are made by people. If you want more details about how your data is processed, you may contact the employer.