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RIO Execution Hub Team Lead

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This job is a leadership role where you'll manage a team ensuring smooth regulatory processes for pharmaceutical products. You might like this job because it involves problem-solving and cross-team collaboration, making a real impact on health compliance!

Undisclosed

Malaysia, Kuala Lumpur

Job Description

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


    Job Requirements


    Company Benefits

    Performance rewards

    Pfizer structures its compensation policies and practices to reward employees based on the contributions they make.

    Health and wellness

    Pfizer offers colleagues health and wellness programs that help them maintain and promote optimum health and wellness.

    Financial support

    Depending on local custom and practice, Pfizer offers several benefits to help employees meet their financial goals!


    Additional Info

    Company Activity

    Last active - few hours ago

    Job Specialisation


    Company Profile

    Pfizer-logo-image

    Pfizer

    We’re celebrating 175 years of daring scientific innovation—and we’re not done yet. Every day, we’re channeling our passion and resources into delivering innovative therapies that change the face of healthcare. Let’s outdo yesterday. We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. It was Charles Pfizer’s vision at the beginning and...