Regulatory Strategist – International, Manager

Syneos Health

. Lead and support submissions in Latin American markets for MAAs and life-cycle management procedures .

Posted 9/22/2026full-timeRemote • ChileMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs within Latin America, including submission planning, preparation, and compliance with local regulations. Proficient in coordinating cross-functional teams and providing regulatory guidance across departments.

Highest-signal resume keywords

Regulatory Affairs ExperienceSubmission PlanningRegulatory Strategy DevelopmentKnowledge of Local RegulationsBachelor’s Degree in Pharmaceutical Sciences

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory ComplianceRegulatory StrategySubmission PreparationRegulatory DocumentationHealth Authority InteractionRegulatory AdviceSubmission TimelinesVeevaCross-Functional Team Leadership

Soft Skills

CommunicationCollaborationFacilitation

Tools & Technologies

Veeva

Industry Keywords

Latin AmericaRegulatory AffairsHealth AuthoritiesPharmaceutical SciencesLife-Cycle ManagementGeographical ExpansionLocal RequirementsRegulatory ChangesSubmission PartnersCross-Functional Teams

About the role

Key responsibilities & impact

Lead and support submissions in Latin American markets for MAAs and life-cycle management procedures
Provide local expertise as a member of the Global Regulatory Affairs team
Drive and coordinate regulatory strategy and local regulatory activities in Latin America
Provide regional regulatory expertise for geographical expansion
Track Health Authorities’ requests and relevant new local regulations
Maintain current knowledge of local requirements and communicate regulatory changes to senior management
Lead cross-functional Vertex teams through submission planning, preparation, submission, and review
Prepare responses to regulatory questions
Prepare timelines and create submission binders in Veeva
Keep submission and correspondence files up to date
Act as local expert for regulatory queries from medical, supply chain, and other functions
Ensure work complies with regulatory requirements and company policies and procedures

Requirements

What you’ll need

Relevant industry experience in regulatory affairs in Latin America
Understanding of current trends in local and regional requirements
Knowledgeable resource for regulatory advice by other departments
Experience interacting with Regulatory Authorities
Ability to facilitate interactions with International Regulatory Affairs, other departments within the Company, and external parties, mainly submission partners
Bachelor’s degree in Pharmaceutical Sciences
Advanced written and spoken English
Knowledge of Spanish and Portuguese considered an advantage

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations when appropriate