RIO Execution Hub (EH) Associate / Sr. Associate

About the role

The EH Associate and Sr. Associate provide operational regulatory support for designated countries, clusters and/or regions. They support submission logistics and technical aspects, ensuring the development and delivery of X-regional, regional and/or national regulatory dossiers from initial application through lifecycle updates, in close partnership with the Country Regulatory Strategist, International Labeling & Artwork and other stakeholders.

Key responsibilities

• Plan regulatory submission timelines and keep regulatory systems up to date
• Manage M1 dossier components (authoring, delivery and coordination of local, submission-ready documents, excluding labeling and artwork)
• Author simple local-only Health Authority query responses and review dossier structure when required
• Escalate submission delays and develop mitigation strategies aligned with impact and risk
• Support tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, launch planning and audit readiness
• Identify opportunities to streamline the regulatory process using digital tools
• Associate: coordinate lower-complexity activities, manage milestones and build independence under guidance
• Sr. Associate: lead project management for submissions (timelines, work plans, risk assessments), handle complex HA queries, represent regulatory operations in project meetings and contribute to forecasting and resource planning

Required profile

• Bachelor's degree (or equivalent) in Pharmacy, Life Sciences, Business or Information Technology (desirable)
• At least 2 years for Associate and 3+ years for Senior Associate
• Fluent English; multilingual skills desirable (Portuguese in LatAm EH)
• Preferred: pharma regulatory, quality and/or compliance experience, familiarity with pharmaceutical organizations and country regulatory requirements

Required skills

• Advanced Microsoft Office Suite
• Quick learning of new software, regulations and quality standards
• Associate: foundational regulatory operations knowledge, clear communication, use of approved AI-enabled tools
• Sr. Associate: independent issue resolution, multi-project management, presentation to local, regional and global teams, responsible use of AI tools