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Subang Jaya

    International Regulatory Affairs Compliance Director - Petaling Jaya, Malaysia - AstraZeneca

    AstraZeneca
    AstraZeneca Petaling Jaya, Malaysia

    Found in: Talent MY C2 - 2 days ago

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    Description

    International Regulatory Affairs Compliance Director

    About AstraZeneca

    At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

    We have an opportunity for a Regulatory Affairs Compliance Director to join our team. International Regulatory Affairs (inRA) drives innovative, international, regulatory and patient-centric strategies, enabling simultaneous global access to our products. The International region consists predominantly of Emerging Markets (Asia, Latin America, Middle East and Africa, Eurasia), with some developed markets. We have a three-pillar strategy in International: Expansion, Innovation and Partnership.

    What you'll do

    As an International Regulatory Affairs Compliance Director, you will lead the development of International Good Regulatory Practices (GRP) strategies. You will collaborate closely with both Marketing Company Regulatory Affairs (MCRA) GRP Leads and Global Regulatory Compliance Team to support the development of GRP policies and standards and execution in international regions.

    Part of the responsibility will be to establish and maintain sustainable GRP framework for international regions following GxP and global regulatory compliance practice. Also, you will act as GRP lead on behalf of international region at senior leadership platforms.

    Responsibilities will include:

  • Ensuring GRP compliance as part of license-to-operate activities for continuity of access of innovative therapies
  • Responsible to oversee the implementation and delivery of global GRP initiatives & KPI of International marketing companies.
  • Coach, support and provide training (where applicable) to MCRA to ensure GRP activities are performed following AZ requirements, standards & processes.
  • Accountable to ensure International MCRA perspective and voice is incorporated and prioritized at Global Regulatory Process & Compliance development strategy and Quality Management System.
  • Lead and strengthen International GRP Network and ensure an active interaction through different channels, including International Best Practice Sharing, Regional Regulatory KPI Forum.
  • Primary point of contact for MCRA on GRP quality system related topics.
  • Training Management: Support onboarding of new GRP Lead and identify MCRA training needs in coordination with global regulatory compliance.
  • Matrix leadership on country GRP Leads to ensure GRP compliance at marketing companies.

    • Education, Qualifications, Skills and Experience

    Essential for the role:

  • Bachelor's degree in a science related field.
  • Experience in Quality Assurance (QA) or GxP Quality Management System (QMS)
  • Experienced with broad understanding of technical requirements with quality mindset and Regulatory Affairs (RA). Preferable experience in RA operations compliance

    • You will also need excellent communication and organization skills and an ability to make decisions and influence outcomes. It will be important with a strong intuition for business with integrity and high ethical standards. Your leaderships skills will be vital, and we believe you have an experience of leading multi-disciplinary project teams.

    Desirable for the role:

  • People management experience
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