Rio Execution Hub Team Lead

2 days ago

Kuala Lumpur, Malaysia Pfizer Full time

Job Description

- 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.

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