RA Specialist (제약, 18개월 계약직, 서울)
发布于 1 天前普通员工/个人贡献者
值不值得投
综合评分 73
A purpose-driven regulatory affairs contract role at a global pharma leader in Seoul, offering strong social impact and career growth but with some long-term stability trade-offs.
从薪资福利、成长发展、工作生活和使命价值四个维度综合评估，方便横向比较。
薪资怎么样
2万
比药品注册中位数低
发布情况
新岗位 · 今天发布
公司情况
这家公司招聘很活跃
约 130 个在招
市场机会
选择适中
药品注册 · 31 个在招
职位详情
关于这个职位
This position is responsible for regulatory registration and compliance management of Merck's pharmaceutical products. You will collaborate with global and local teams to ensure timely and compliant submission of new marketing authorizations and variations, while monitoring regulatory changes and maintaining stakeholder relationships.
最低要求
Bachelor's degree in Pharmacy or a related field.
工作职责
Achieve new product registration in collaboration with the Global team and related local functions to get the best product registration with commercially attractive labelling.
优先资格
Prior experience in Regulatory Affairs is preferable.
AI 洞察
优缺点分析
优点
- Opportunity to work with a top-tier global pharmaceutical company, gaining exposure to innovative therapies in oncology, neurology, and fertility.
- Develop a comprehensive understanding of both local and global regulatory frameworks, enhancing your professional market value.
- Experience a diverse, inclusive, and flexible work culture with a strong emphasis on career development.
- The role is an 18-month contract, which may lack long-term job stability compared to permanent positions.
- Navigating complex and frequently changing legislative requirements can be highly demanding and stressful.
- This role is ideal for early-career pharmaceutical professionals with a strong interest in regulatory compliance, who thrive in a dynamic, global environment and are looking to build a solid foundation in RA.
缺点 / 挑战
暂无明显挑战项
角色解读
- Progress from a Regulatory Specialist to a Senior RA Specialist or RA Manager, taking on more complex product portfolios.
- Transition into broader regulatory strategy roles or cross-functional leadership positions within the healthcare business unit.
- Manage and execute regulatory submissions for new product registrations and variations in compliance with local and global regulations.
- Monitor legislative changes and ensure packaging materials and promotional activities comply with regulatory standards and KRPIA codes.
- Collaborate with cross-functional teams and external stakeholders to achieve commercially attractive product labeling.
- Solid understanding of pharmaceutical regulatory affairs and registration processes in South Korea.
- Strong cross-cultural communication and collaboration skills, with native Korean and proficient English.
- Attention to detail and ability to monitor strategic legislative issues and audit progress.
申请策略
- Tailor your resume to explicitly mention your experience with product registration, variations, and promotional material compliance.
- Prepare to discuss how you handle tight deadlines and complex regulatory changes in your previous roles.
- Highlight your experience in the pharma industry, specifically focusing on any regulatory submission or compliance projects.
- Emphasize your bilingual capabilities and any experience collaborating with global teams.
- Showcase your Pharmacist License if you have one, as it is a strong preferred qualification.
- Deepen your knowledge of Korean pharmaceutical regulations and global ICH guidelines.
- Improve your cross-functional communication skills and project management abilities to handle multiple registration plans simultaneously.
面试指南
- Use the STAR method to structure your answers, focusing on specific regulatory projects you've handled.
- Emphasize your proactive approach to monitoring regulatory changes and your collaborative mindset when working with global and local teams.
- Can you walk us through your experience with submitting new marketing authorization applications or variations?
- How do you stay updated with changes in legislative requirements, and can you give an example of how you adapted to a recent change?
- Describe a time when you had to collaborate with cross-functional teams to achieve a commercially attractive label.
- How do you ensure compliance in promotional materials and packaging?
- Review the latest Korean MFDS guidelines and the company's therapeutic focus areas.
- Prepare examples that demonstrate your attention to detail, teamwork, and ability to work under tight deadlines.
职位点评
薪资福利
The position offers a competitive market salary for a regulatory specialist in Seoul, but the 18-month contract nature introduces some uncertainty regarding long-term financial stability.
成长发展
Working with a global healthcare leader provides excellent exposure to innovative therapies and global regulatory frameworks, supported by the company's emphasis on career development.
工作生活
The JD mentions a flexible work culture and diverse environment, but specific details on working hours or remote work policies are not explicitly stated.
使命价值
The role is deeply connected to the company's mission of creating, improving, and extending lives through innovative healthcare solutions, offering a strong sense of social purpose.
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