Regulatory Affairs Executive at Takeda in Hanoi, Hanoi, Vietnam

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Job Description

About the role:

The job requires the person to manage Regulatory Affairs for allocating products to ensure regulatory submissions, product registrations, and license maintenance to ensure ongoing compliance with Vietnamese regulatory requirements and Takeda policies. Support product availability and business objectives through effective execution of regulatory activities and proactive stakeholder collaboration.

How you will contribute:

• Manage routine regulatory submissions and maintenance activities for assigned products.
• Support product registration, license renewals, variations, and compliance reporting.
• Track and communicate regulatory requirements, approvals, and license changes.
• Manage timely submission of PSUR/PBRER to the regulatory authority for the assigned products.
• Maintain regulatory documentation and records in accordance with company procedures.
• Coordinate with regulatory authorities and internal stakeholders to facilitate timely regulatory activities.
• Provide day-to-day regulatory support to business and functional teams.
• Ensure compliance with applicable regulations, Takeda policies, and regulatory SOPs
• Engage in frequent internal and external interactions to foster productive relationships

Skills and qualifications:

• Bachelor’s degree in pharmacy, Medicine, Life Sciences, or a related discipline.
• Minimum 2-3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Experience supporting product registration, regulatory submissions, and lifecycle management activities.
• Familiarity with local pharmaceutical regulations, regulatory requirements, and compliance standards.
• Experience liaising with health authorities and supporting regulatory communication is preferred.
• Strong attention to detail with the ability to prepare, review, and maintain regulatory documentation accurately.
• Good planning, organizational, and time management skills, with the ability to manage multiple priorities and meet deadlines.
• Good command of written and spoken English

Locations

Hanoi, Vietnam

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time