Regulatory Affairs Head – Chile & Ecuador

About the role

The Regulatory Affairs Head for Chile and Ecuador will lead the implementation of the global regulatory strategy across these markets, ensuring timely submissions and approvals while aligning with business objectives. This senior position partners closely with regional teams, health authorities and internal stakeholders to drive regulatory excellence.

Key responsibilities

• Implement the global regulatory strategy and contribute to the Regional Functional Plan for Chile and Ecuador.
• Coordinate and submit dossiers, Clinical Trial Applications (CTAs), Investigational New Drugs (INDs) and Risk Management Plans to health authorities.
• Serve as the primary liaison with local health authorities (e.g., FDA, EMA) and manage briefing books and summary documents.
• Develop and execute plans to avoid clock‑stops during submission reviews and ensure timely responses to authority queries.
• Lead negotiations for regional approvals, either independently or with DRA representatives.
• Report technical complaints, adverse events and special case scenarios within 24 hours of receipt.

Required profile

• Pharmacy degree or a related scientific field.
• More than 5 years of experience leading a Regulatory Affairs function.
• Proven experience working with professional associations, industry organizations or trade chambers (preferred).
• Strong negotiation and influencing abilities.
• Flexible, agile mindset with a focus on team development to achieve ambitious results.

Required skills

• Clinical Trial Applications (CTAs) preparation and submission.
• Investigational New Drugs (INDs) review and filing.
• Risk Management Plans development.
• Regulatory dossier preparation and submission.
• Health Authority interaction and negotiation.