Regulatory Strategist – International, Manager

Syneos Health

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

Posted 11/5/2026full-timeRemote • BrazilMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory affairs within Latin America, including submission management, compliance with local regulations, and effective communication with regulatory authorities. Proficient in coordinating cross-functional teams and maintaining up-to-date knowledge of regulatory changes and best practices.

Highest-signal resume keywords

Regulatory Affairs ExperienceSubmission ManagementRegulatory Strategy DevelopmentCross-Functional Team LeadershipBachelor's Degree in Pharmaceutical Sciences

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory SubmissionsLocal Regulatory RequirementsCTD KnowledgeGMP KnowledgeRegulatory Compliance

Soft Skills

Interdepartmental CommunicationFacilitation SkillsExpertise in Regulatory Advice

Tools & Technologies

Submission BindersCorrespondence Files

Industry Keywords

Latin AmericaHealth AuthoritiesLife-Cycle ManagementRegulatory ChangesPharmaceutical Sciences

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 and help establish and implement best practices
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 and forward them to the relevant GRA contact
Maintain current knowledge of local requirements and communicate regulatory changes to Regulatory Senior Management
Lead cross-functional teams in preparing submission activities from planning through submission and review, including responses to questions
Support submission leads by preparing timelines, creating submission binders, and maintaining submission and correspondence files
Act as local expert for regulatory queries from other functions, including medical and supply chain, on regulatory requirements, local labelling guidance, CTD, and GMPs
Ensure all 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
Recognized as a 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