高德美(瑞士证券交易所:股票代码为"GALD") 致力于成为专注皮肤学领域的全球领导者,业务遍及约90个国家和地区。我们提供创新、以科学为基础的优质旗舰品牌和服务组合,横跨注射美学、日常护肤和皮肤治疗这三个快速增长的皮肤学细分市场。自1981年成立以来,我们一直热忱专注于人体最大的器官——皮肤,与专业医务工作者合作,以卓越成果满足求美者、消费者和患者的个性化需求。肌肤塑造了我们的人生故事,由此,我们致力于不断推进"每一个进步 为每一寸肌肤"。更多信息请访问
我们欢迎专注于成果、乐于学习并能带来积极能量的同事加入我们。他们需要将主动性,团队合作和协作精神完美结合。最重要的是,他们必须为我们每天服务的消费者、患者和医疗行业人士做有意义的事情而充满热情。我们致力于赋能每位员工,促进他们的个人成长,同时确保当前和未来的业务需求得到满足。在高德美,我们拥抱多样性,尊重每一位员工的尊严、隐私和个人权利。我们坚信,致力于成为世界领先的专业皮肤学公司是我们共同的雄心抱负。加入我们,您将有机会获得具有挑战性的工作经历的绝佳机会,并创造无与伦比的直接影响。
Job Title: Regulatory Affairs Supervisor
Location
: Shanghai/ Beijing, China
Job Description
- Manage registration dossiers. Ensure accurate and timely preparation of regulatory submissions of new products, variation and maintenance of existing registration to obtain timely approval of product registration from NMPA/Local FDA.
- Provide regulatory guidance, consultation, interpretation and advice to relevant departments to ensure compliance with regulatory guidelines/directives/national requirements.
Key Responsibilities
- Work with global team and local team to prepare for registration /notification submission and follow up of files required for cosmetic license for new, renewal and change projects, address question raised by NMPA/ SH FDA to get approval in a timely manner.
- Ensure regulatory compliance in terms of product formula, raw materials and claims
- Monitor cosmetic promotional operations (training material, product leaflet, brochure etc.) for compliance
- Maintain good communication with regulatory agencies/institutes (e.g., CDC, SGS, PONY) on product registration and testing, ensure expected testing result and testing proceeded per timeline .
- Establish and consolidate the relationship with internal and external key stakeholders
- Monitor regulatory environment in China with regards to standards, literature, regulations, guidance documents etc. Analyses the impact to the company and shares with the relevant functions
- Provide regulatory guidance, consultation, interpretation and advice to relevant departments to ensure compliance with regulatory guidelines/directives/national requirements
- Achieve submitted documentations and ensure traceability
Skills & Qualifications
- BA degree in Chemistry, compound or pharmacy or a combination of education and experience providing equivalent knowledge or above
- Minimum 3 or above years' experience in Regulatory Affairs for Cosmetics
- Extensive knowledge of cosmetic regulations and technical requirements in China
- Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with global/local project team personnel.
- Demonstrated ability in project management skills in order to plan, conduct and implement regulatory submissions
- Skill in determining alternatives that would correct a situation to comply with standards and regulations
- Good level of communication both in Chinese and English
What We Offer In Return
At Galderma, you have the opportunity to gain new and challenging work experience and create an unparalleled, direct impact. We offer careers in innovation and accountability, empowered by diverse, collaborative colleagues across functions and geographies who share their passion to advance dermatology for every skin story.
Our people make a difference
At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.