RIO Execution Hub Team Lead

Job Description

The RIO Execution Hub Team Lead oversees a team of Hub Managers and Specialists who support regulatory operations across countries and clusters. This role ensures timely, high-quality regulatory submissions and sustained compliance throughout the product lifecycle—from initial applications to product withdrawal. Responsibilities include:

• Leading regulatory dossier management and lifecycle activities.
• Acting as the primary contact for issue resolution and escalation.
• Supporting cross-functional regulatory needs (e.g., tenders, out-of-stock reporting, launch planning).
• Overseeing local document authoring, health authority query responses, and audit readiness.
• Partnering with the RIO Submissions Hub Team Manager to ensure submission quality and compliance.
• Driving operational performance, process efficiency, and continuous improvement.
  
  

Education Qualifications

• Bachelor’s or Master’s degree (e.g.,Pharmacy, MS, MBA) in a scientific, technical, or information management discipline.
  
  

Required Competencies

• Regulatory Expertise: Deep understanding of global, regional, and cluster regulatory requirements. Preferably 10 years or more experience in regulatory affairs in Pharmaceutical Industry, with experience across different market within Asia.
• Leadership: Proven experience in leading regulatory strategy and operations teams.
• Business Acumen: Strong judgment, planning, and decision-making skills.
• Communication: Ability to convey complex information clearly to diverse audiences.
• Change Management: Experience in implementing business change and managing cross-site teams.
• Collaboration: Skilled in relationship-building across functions and cultures.
• Compliance & Quality: Commitment to audit readiness, SOP adherence, and KPI tracking.
• Innovation & Agility: Ability to adapt in real-time, foster continuous improvement, and drive results.
• Technical Proficiency: Experience with submission and portfolio management, including eCTD and dossier publishing.
• Project management: Proven capability to successfully manage Projects. Formal Certifications will be an added advantage
  
  

Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs