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Job Summary Global CRO is actively seeking a Regulatory Affairs Supervisor for international markets. This position will lead the regulatory submission efforts for our products abroad, ensuring compliance with international regulations and standards, and supporting the company's global business expansion. We are looking for a candidate with extensive experience and expertise to drive our globalization strategy. 2. Responsibilities Handle the regulatory submission process for our products in international markets, ensuring the timeline and quality of registrations. Develop and implement strategies for international registrations to ensure compliance with global regulatory requirements. Communicate with regulatory authorities in various countries to address issues during the registration process. Prepare and review regulatory submission documents to ensure their accuracy and completeness. Monitor and stay updated with regulatory changes and policies in different countries, adjusting registration strategies as needed. Organize and coordinate cross-departmental teams to ensure smooth progress of registration projects. Participate in the development of international market expansion strategies, providing professional advice and support. 3. Qualifications Mandatory: Bachelor’s degree or higher, preferably in Pharmacy, Medicine, Life Sciences, or related fields. At least 3 years of regulatory experience, including a minimum of 2 years in international regulatory affairs. Experience in writing and revising regulatory documents. Familiarity with at least two of the following product types: active/non-active/IVD. Work location: Suzhou, on-site. Fluent in English (listening, reading, writing). Preferred: Experience managing projects from initiation to certification, with independent experience in writing CERs. Experience with Class III high-risk medical devices. Fluent in speaking, reading, and writing English. 4. Welfare after full-time employment At MDCE, we attach importance to the well-being of our employees. In addition to providing essential welfare protection, we have implemented a range of policies that promote a humane and employee-friendly workplace. Here's an overview of the benefits we offer: Rich holidays & Work From Home (WFH) Diverse Leave & Holidays: This includes regular weekends (Saturday & Sunday), 5 days of supplementary annual leave, 5 days of fully paid sick leave, as well as marriage and funeral leave. Furthermore, we offer 158 days of maternity leave for eligible employees. Work From Home: Employees can choose to work from home on the day preceding public holidays, providing added flexibility and convenience. Comprehensive Health Security Comprehensive Insurance Coverage: Employees enjoy coverage under the five insurances (such as social security, medical, and unemployment insurance) and the housing provident fund. Supplementary Family Medical Insurance: To support the health and well-being of our employees and their families, we provide comprehensive supplementary medical insurance with nearly 80%-90% coverage. Annual Physical Examinations: We organize and cover the cost of annual physical examinations for our employees, ensuring their well-being and early detection of health concerns. Vibrant Corporate Culture & "Supply Station" Regular Team Building Activities: We organize team-building events on a regular basis to strengthen team bonds and encourage collaboration among employees. Birthday Celebrations: Each employee's birthday is celebrated, fostering a sense of appreciation and warmth within the workplace. Snacks, Drinks & Afternoon Tea: We provide a selection of daily snacks and drinks, as well as regular afternoon tea, to create a comfortable and enjoyable work environment. Comprehensive Emolument System Reasonable Structure: Our salary system includes a well-structured combination of a competitive basic salary, performance-based bonuses, and various subsidies. Opportunities for Salary Increase: Recognizing the value of our employees' contributions, we conduct periodic salary adjustments based on individual performance.Похожие вакансии