LatAm Regulatory Strategy Lead

Syneos Health, Inc.; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Syneos Health, Inc. is seeking a Regulatory Strategist - Intl (Mgr) to lead regulatory strategy and submissions across Latin American markets in coordination with the Global Regulatory Affairs team.

You will monitor local requirements, liaise with health authorities, and guide cross-functional teams from planning through submission while ensuring timely, compliant outcomes in a fast-paced, global environment.

Qualifications

• Relevant industry experience in regulatory affairs in Latin America
• Recognized as a knowledgeable resource for regulatory advice by other departments
• Experience of interacting with Regulatory Authorities
• Able to facilitate interactions with International Regulatory Affairs and other departments
• Advanced written and spoken English and knowledge of Spanish and Portuguese will be considered an advantage

Responsibilities

• Drive regulatory strategy and local activities in Latin America for geographical expansion
• Track Health Authorities’ requests and new local regulations and forward to GRA contact
• Maintain knowledge of local requirements and communicate changes to Regulatory Senior Management in a timely manner
• Lead cross-functional team to prepare submission activities from planning through to submission and review
• Prepare timelines and submission binders and ensure submission and correspondence files are up to date
• Provide local regulatory expertise and communicate changes to local and RA Senior Management in a timely manner
• Act as local expert for regulatory queries from other functions (e.g., medical and supply chain)
• Ensure all work is compliant with regulatory requirements and company policies and procedures

Skills

Regulatory strategy

Regulatory submissions

Interdepartmental collaboration

English proficiency

Education

Bachelor's degree in Pharmaceutical Sciences

Job description

Syneos Health, Inc. is seeking a Regulatory Strategist - Intl (Mgr) to lead regulatory strategy and submissions across Latin American markets in coordination with the Global Regulatory Affairs team.

You will monitor local requirements, liaise with health authorities, and guide cross-functional teams from planning through submission while ensuring timely, compliant outcomes in a fast-paced, global environment.