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Regulatory Affairs Specialist - HCM

Company

AstraZeneca

Location

Ho Chi Minh City, Vietnam

Type

Full time

Typical Accountabilities:

  • Maintain in-depth knowledge of key product-related areas, including commercial strategy, dossier content, regulatory intelligence, regulatory timelines, and supply strategy.

  • Develop and implement milestone plans for drug registrations.

  • Prepare high-quality regulatory submissions and manage product registrations for new applications, license extensions, and variations.

  • Develop packaging artwork to support new product launches and lifecycle management.

  • Provide detailed updates on the regulatory status of impacted products and advise on appropriate regulatory pathways and processes.

  • Maintain regulatory compliance databases and associated processes.

  • Monitor registration activities to ensure timely submission and approval of new product registrations, license extensions, and regulatory changes, aligned with company strategic business goals.

  • R...

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