LATAM Regulatory Strategist – Remote

Syneos Health, Inc.; México; A distancia; MXN 600.000 - 800.000; Jornada completa

Descripción de la vacante

Syneos Health in Mexico is seeking a Regulatory Affairs Consultant to lead LATAM submissions and ensure regulatory compliance across the region. You will coordinate strategy, track health authority requests, and collaborate with internal teams to advance approvals.

Strong English and local/regional regulatory knowledge are required, with Portuguese/Spanish considered an advantage for cross-border collaboration.

Formación

• Relevant industry 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 of interacting with Regulatory Authorities.
• Ability to facilitate interactions with International Regulatory Affairs, other departments, and external partners.

Responsabilidades

• Drive and coordinate regulatory strategy and local regulatory activities in Latin America and provide regional regulatory expertise for geographical expansion.
• Track all Health Authorities’ requests and relevant new local regulations and forward to relevant GRA contact.
• Maintain current 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 to submission and review, including responses to questions.
• Act as support to submission lead by preparing timelines and submission binders in Veeva and maintaining up-to-date files.
• Provide local regulatory expertise and anticipate/communicate changes to local and RA Senior Management.
• Act as local expert for regulatory queries from other functions on topics such as regulatory requirements, local labelling guidance, CTD and GMPs.
• Ensure all work is compliant with regulatory requirements and company policies and procedures.

Conocimientos

Regulatory strategy

Latin America

Submission management

Veeva

Cross-functional

English proficiency

Educación

Bachelor's degree in Pharmaceutical Sciences

Herramientas

Veeva

Descripción del empleo

Syneos Health in Mexico is seeking a Regulatory Affairs Consultant to lead LATAM submissions and ensure regulatory compliance across the region. You will coordinate strategy, track health authority requests, and collaborate with internal teams to advance approvals.

Strong English and local/regional regulatory knowledge are required, with Portuguese/Spanish considered an advantage for cross-border collaboration.