Regulatory Strategist – International (Manager)

About the role

Syneos Health is seeking an experienced Regulatory Strategist to lead and support submissions in Latin American markets. The role will be part of the Global Regulatory Affairs team, driving strategy and ensuring compliance across the region.

Key responsibilities

• Drive and coordinate regulatory strategy and local activities for Latin America, supporting geographical expansion.
• Track health authority requests and new local regulations, forwarding relevant information to the GRA team.
• Lead cross‑functional teams from planning through submission, including preparation of timelines, submission binders, and response to authority questions.
• Provide local regulatory expertise, advise on labeling, CTD, GMPs, and act as the point of contact for regulatory queries from medical and supply‑chain functions.
• Ensure all work complies with regulatory requirements, company policies, and procedures.

Required profile

• Significant experience in regulatory affairs within Latin America, with a solid understanding of current trends and local requirements.
• Proven ability to interact with regulatory authorities and facilitate collaboration with international regulatory affairs and external submission partners.
• Bachelor’s degree in Pharmaceutical Sciences or a related field.
• Advanced written and spoken English; knowledge of Spanish and Portuguese is an advantage.

Required skills

• Regulatory submissions and lifecycle management for MAAs in Latin America.
• In‑depth knowledge of Latin American regulatory requirements and health authority processes.
• Ability to prepare and manage submission documentation, timelines, and correspondence files.