Regulatory Strategist – International (Manager)

About the role

The Regulatory Strategist – International (Manager) will lead and support regulatory submissions across Latin American markets, driving strategy and ensuring compliance throughout the product lifecycle.

Key responsibilities

• Drive and coordinate regulatory strategy and activities in Latin America, providing regional expertise for market expansion.
• Track health authority requests and new local regulations, communicating changes to senior management.
• Lead cross‑functional teams from planning through submission, preparing timelines, binders and response documents.
• Act as the local expert for regulatory queries from medical, supply‑chain and other functions, covering labeling, CTD, GMP and related guidance.

Required profile

• Significant experience in regulatory affairs within Latin America, with a strong understanding of local and regional requirements.
• Proven ability to interact with regulatory authorities and facilitate collaboration with international regulatory affairs and external partners.
• Bachelor’s degree in Pharmaceutical Sciences or related field.

Required skills

• Regulatory affairs expertise (MAA submissions, lifecycle management).
• Knowledge of Latin American regulatory environments, including labeling, CTD and GMP.
• Advanced written and spoken English; Spanish and Portuguese are advantageous.