Remote LATAM Regulatory Strategy Manager

Syneos Health, Inc.; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Syneos Health is seeking a Regulatory Affairs Manager to oversee submissions in Latin American markets and provide local expertise as a member of the Global Regulatory Affairs team. This remote role supports MAAs and lifecycle management procedures and helps establish best practices across regions.

Join a global team that collaborates across functions to ensure timely, compliant submissions and effective regulatory strategies for market access, while maintaining strong relationships with local

Qualifications

• Experience in regulatory affairs in Latin America and understanding of local/regional requirements.
• Recognized as a knowledgeable resource for regulatory advice by other departments.
• Experience interacting with Regulatory Authorities.

Responsibilities

• Lead and support submissions in Latin American Markets for MAAs and lifecycle management procedures.
• Track Health Authorities’ requests and relevant local regulations and forward to GRA contacts.
• Maintain knowledge of local requirements and communicate changes to Regulatory Senior Management.
• Lead cross-functional teams to prepare submissions from planning to review and respond to questions.

Skills

Regulatory expertise

English proficiency

Spanish/Portuguese advantage

Education

Bachelor’s degree in Pharmaceutical Sciences

Job description

Syneos Health is seeking a Regulatory Affairs Manager to oversee submissions in Latin American markets and provide local expertise as a member of the Global Regulatory Affairs team. This remote role supports MAAs and lifecycle management procedures and helps establish best practices across regions.

Join a global team that collaborates across functions to ensure timely, compliant submissions and effective regulatory strategies for market access, while maintaining strong relationships with local