RA经理 法规经理 （999962）
| 职位信息 |
| 职位名称： |
RA经理 法规经理 |
职位类别： |
人事/行政类 |
| 工作性质： |
全职 |
应聘/招聘人数： |
0/1 |
| 工作地区： |
太仓港区 |
作息制度： |
双休 |
| 住房食宿： |
|
月薪水平： |
面议或未公开 |
| 工作描述： |
RESPONSIBILITIES 主要职责：
·Responsible for regulatory affairs of durex condoms produces at TC.
负责太仓工厂杜蕾斯避孕套产品法规事务。
·Lead championing procedures to expedite commercialization of new products in scope.
领导团队支持新产品的市场准入工作。
·Managing regulatory processes to ensure timely filing, approval and renewal of new product and new labeling registrations in accordance with business objectives.
依照公司计划和产品注册程序规定，管理团队实现申请和准备产品注册相关文档。
·Maintain product registration licenses and manufacturing license, make necessary alteration and provide regulatory supports to ensure business compliance with prevailing regulations.
维护产品注册证和生产许可证，进行必要的变更，并提供法规支持，以确保业务符合现行法规。
·Builds relationships and negotiates with local regulatory agencies and associations on all matters relating to products development, compliance and safety related matters in China market.
与当地政府部门和相关协会建立良好的联系和沟通，助推产品在市场的良好发展、与业务相关法规事务及安全问题进行积极沟通。
·Lead abreast of regulatory changes, ensure efficient and effective communication with appropriate management team and to local and global regulatory, local commercial teams and other cross-function groups.
及时了解和更新政策法规，并及时与公司业务部门和其他相关部门进行有效沟通。
·Works with Quality and Brand Managers to ensure all promotional materials and all activities in line with local regulatory requirements.
与各职能部门及品牌负责人合作，确保促销物料以及商业活动符合法规要求。
·Follows up relentlessly with HQ regulatory affairs people to solicit input and support to be in-line with Worldwide registration efforts.
与总部法规同事密切联系，获得其最新信息及支持文件，以保持与全球注册计划同步。
·Establishes strong working relationships with business colleagues within RB to ensure all efforts are focused on successful commercialization.
与业务同事建立密切的合作关系，为公司相关产品的成功商业化共同努力。
·Strategic thinking and plan, provide clear direction to team members, full of responsibility, pay strict attention to details and accuracy whilst maintaining sense of urgency.
工作有战略思维、可以给团队清晰的指导、富有责任心、细心、准确、有效率。
Knowledge and Skills required
学历及技能要求
1)Education/Major：University science degree or above in a relevant scientific discipline, with bioscience, chemistry or pharmacy related is a plus.
教育程度/专业：大学本科及以上学历，具有生物学、化学、药学相关专业优先。
2)Experience in regulatory in medical device industry within an MNC environment.
拥有跨国企业医疗器械相关法规事务经验，具有团队管理经验。
3)ISO9001 experience required, ISO 13485 experience desired.
要求有ISO 9001经验，有ISO 13485经验者优先。
4)Eng. (Read/Written/Oral): Fluent 英文程度（读/写/说）：流利
5)PC Skills: Good电脑技能：熟练
Experience Desired经验要求：
·Preferably with at least 8 years experiences in medical device regulatory function.
拥有8年以上医疗器械法规经验更为适宜。
·Demonstrated ability to negotiate with people of various internal and external functions.
拥有良好的部门内外沟通能力。
·Experience in project management and demonstrated ability in time management.
拥有项目管理经验和良好的时间管理能力
·Experience on medical device related quality experience will plus
医疗器械质量相关工作经验优先
·Lead team in planning and problem solving.
领导团队策划、解决问题
·Demonstrated ability to work with a range of technically and culturally diverse people, influencing them to get things done, and delivering value-added business results that meet high quality requirement within tight deadlines.
拥有与不同技术才能、文化背景的员工沟通能力，通过自身影响力为公司商业活动增值，能在有限的时间内实现高水平的目标。
Knowledge Desired 知识要求：
·Knowledge of local/regional regulatory processes and changes that are implemented or being considered.
了解当地/区域法规流程和正在实施或正在考虑的变更。
·Knowledge of the local related industry
了解当地相关产业情况。
·Good influencer in organization structure and policies of related Authorities and trade association
熟悉相关政府主管机构和行业协会的组织结构，可以积极参与并有效影响政策制定。
·Good understanding of Reckitt products and procedures, clear in local regulatory detailed requirements.
了解利洁时产品特性及其相关法规程序, 了解当地法规政策对其分属领域的具体要求。
·Reasonable command in oral and written English communication skills.
拥有英语写作及口语沟通能力
Developmental Value: 更高要求：
·Awareness of the importance of cross-functional networks to achieve business results.
重视跨部门团队协作以达到公司商业活动目标
·Greater contact with government regulatory authorities
与政府法规部门有密切的接触
·Outstanding influencer internally and externally
拥有卓越影响力 |
| 应聘要求 |
| 学历要求： |
本科 |
专业类别： |
不限 |
| 专业名称： |
不限 |
户籍要求： |
不限 |
| 适宜性别： |
不限 |
|
|
| 年龄要求： |
不限 |
工作经验： |
5 年 |
| 外语能力： |
英语 精通 |
计算机能力： |
熟练 |
| 技能资质： |
不限 |
| 其它要求： |
不限 |
| 职位首次录入： |
2024-01-23 11:42:35 |
| 职位二维码： |
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