Regulatory Affairs Specialist (North America, LATAM, EU)

Role overview

This position is responsible for handling the daily delivery of global regulatory affairs support. The work centers on clinical trial submissions to competent authorities, ethics committees, and regulatory agencies, along with researching, reviewing, and reporting on worldwide regulatory requirements. The role also involves building stakeholder resources, preparing and managing regulatory risk assessments, and offering expert guidance while representing the function with internal teams, sponsors, researchers, and external authorities. The expectation is to maintain strong, timely service delivery in line with company, industry, and regulatory standards. Depending on business needs, the person may also coach colleagues and contribute to staff performance reviews.

Unit management

• Oversee the everyday delivery of regulatory services and workflows, including the preparation of filings, submissions, and revisions for projects, external vendors, and clinical sites.
• Carry out or support regulatory and safety reviews, develop tools and training materials related to regulatory work, and stay up to date on clinical research regulations and current industry practices, sharing relevant updates promptly with project leads.

Client services

• Act as the internal authority on regulatory affairs by giving guidance and support on regulatory, ethics, and pharmacovigilance matters to project stakeholders.
• Represent the team in project meetings, support education and tool creation, participate in regulatory reviews and audits, interface with clients to manage expectations, liaise with regulatory, ethics, and government bodies, and respond to regulatory questions on behalf of the client when needed.

Regulatory strategy development

• Track changes in clinical research regulations and industry standards, then recommend, implement, and maintain regulatory strategies in partnership with other specialists such as safety and quality assurance to meet or surpass compliance expectations.
• Attend specialized conferences and meetings to strengthen knowledge when required.

Project support

• Respond to registration requests on an ongoing basis and work with project teams to determine applicable regulatory requirements.
• Help prepare regulatory submissions and supporting summaries.
• Make sure project and site files are created, updated, archived, and destroyed according to project and regulatory rules, and ensure stakeholders are informed and trained on all relevant requirements.

Qualifications

Applicants 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 fluent written and spoken English and Spanish.

Working conditions

• The role is home-based.
• Reasonable accommodations for candidates with disabilities are available upon request.

Additional information

AI tools may be used in parts of the hiring process, including application review, resume analysis, response assessment, and spotting possible inconsistencies or verification signals in application materials based on the information provided. These tools support the recruitment team but do not replace human judgment, and final hiring decisions are made by people. If more details about data handling are needed, candidates can contact the company.