The RIO Execution Hub Team Lead manages a team overseeing regulatory operations, ensuring compliance through the product lifecycle and driving process efficiency.
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:
Education Qualifications
Required Competencies
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
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
Top Skills
Dossier Publishing
Ectd
Submission And Portfolio Management
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