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[담당업무] This role plays a critical part in interpreting global regulatory guidelines and translating them into actionable local requirements, ensuring continuous product availability and adherence to national regulations.
Reporting to the RA Manager and partnering closely with cross-functional stakeholders such as QA, Sales, and Marketing, you will contribute to regulatory documentation, support license maintenance activities, and facilitate communication with health authorities to enable timely approvals and updates.
Prior experience in healthcare, pharmaceuticals, or MedTech regulatory processes is highly valued.
·Key Responsibilities
[Regulatory Affairs ]
• Product registration of medicinal products and medical devices and life cycle management of product licenses
• Manage regulatory projects related to South Korea including regulatory maintenance
• Monitor policy updates and report key changes under guidance
• Support the maintenance of local RA SOPs to meet BRACCO SOPs and local regulations.
[Pharmacovigilance]
• Manage the documentation and tracking of PV activities in the BIK Office under the supervision of the RA Manager, ensuring compliance with local regulations and BRACCO SOPs, and keeping the system updated in a timely manner.
• Communicate with HQ under the guidance of the RA Manager to keep PV-related agreements up to date and support the coordination of contract compliance requirements.
• Support preparation activities for internal audits and assist with CAPA tracking
• Submit relevant drug safety reports to the local health authority within timeline if these are required by the local regulations.
Skills and Competencies
To succeed in this role, you should have:
• A Bachelor’s degree in a relevant discipline
• Licensed Pharmacist
• Fluent in English
• Over 1 year experience in the pharmaceutical industry
• experience in medical device regulatory affairs is considered a strong plus
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