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Regulatory Affairs Manager

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Primary Location: Seoul, Korea, Republic of Full time R1294746

Job description

You will be responsible for regulatory activities including approvals of NDA/BLA/Variations and maintenance, marketing authorization transfers, communication with the Health Authority, artwork approval, etc. ensuring regulatory compliance in the applicable market(s).
As part of the IQVIA Regulatory Affairs & Drug Development Solutions (RADDS) (formerly Global Regulatory Affairs), you will be working with our clients – global pharmaceutical companies.

Qualifications
• Bachelor’s Degree in Pharmacy, Life Sciences or professional equivalent
• 7+ years regulatory expertise in country-specific requirements for medicinal products including the supervision and creation of country-specific regulatory submission documents and coordinating delivery to submission plans, artwork review, communication with the Health Authority (차장/부장급)
• Experience with working in a large regulatory organization where some tasks are managed centrally and some at a local level
• Knowledge of local pharmaceutical legislation, relevant guidelines and requirements
• Excellent regulatory project management skill set
• Regulatory technology experience is a plus
• Excellent organization and communication skills
• Ability to work to tight timelines
• Good team player
• Excellent written and verbal communication skills in English
• Strong computer skills, including MS Office applications, and preferably, experience with Regulatory Information management and artwork systems

Key Responsibilities
• Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries
• Submit submissions such as renewals/ variations/ new applications filings/ MAH transfers to the local Health Authority and follow up on the local regulatory approval process for designated countries
• Preparation of local Product Labelling (e.g. SmPC, PIL), in local language for designated countries
• Artwork review and approval in client systems
• Promotional materials review and approval in client systems
• Manage multiple pharmaceutical products
• Act as subject matter expert in regulatory processes
• Keep up to date on latest local pharmaceutical legislation, relevant guidelines and requirements
• Perform other tasks or assignments, as delegated by Regulatory management
• Manage meetings with Regulatory Agencies
• Perform other duties, as business needs require

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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