Rio Execution Hub (EH) Manager - Regulatory Operations

About the role

Pfizer is looking for an Execution Hub (EH) Manager, Senior Manager, to provide operational regulatory support for designated countries, clusters and/or regions. The role covers 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 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
• Author, review and maintain Module 1 dossier components (excluding labeling and artwork), and coordinate their receipt, translation, compilation and submission readiness
• Manage complex regulatory submissions (growth and complex lifecycle) and lead project management, timelines, work plans, risk assessments and mitigation strategies
• Author simple Health Authority query responses and coordinate complex ones with the Country Regulatory Strategist
• Support tenders, out-of-stock reporting, Annual Product Quality Reviews, audit readiness, risk minimization plans and launch planning
• Track performance against KPIs, quality metrics and audit requirements, and escalate submission delays with mitigation plans
• Lead or contribute to continuous improvement and transformation projects, and support digital and automation solutions

Required profile

• Bachelor's degree (or equivalent) in Pharmacy, Life Sciences, Business or Information Technology; Master's level desirable
• Minimum 5+ years for Manager, 7+ years for Senior Manager
• Fluent English; multilingual skills desirable (Portuguese in Latin America)
• Preferred: pharma regulatory, quality and compliance experience, familiarity with pharmaceutical organizations, and understanding of country regulatory requirements
• Leadership of complex portfolio activity and matrix management experience for Senior Manager

Required skills

• Advanced Microsoft Office Suite
• Strong regulatory operations and submission management expertise
• Ability to quickly learn new software, regulations and quality standards