Pfizer

RIO Execution Hub Team Lead

Posted 4 Days Ago

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2 Locations

Hybrid

Expert/Leader

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

The RIO Execution Hub Team Lead manages a team overseeing regulatory operations, ensuring compliance through the product lifecycle and driving process efficiency.

Summary Generated by Built In

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

Top Skills

Dossier Publishing

Ectd

Submission And Portfolio Management

What the Team is Saying

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.