东莞招聘

(Senior) Specialist, Global Regulatory Affairs CMC Writer （高级）专家， 全球监管事务CMC作家

Location: Beijing or Shanghai, On-site.
Deliverable：
1. To complete the CMC Writing to support regulatory submission dossier with agreed timelines depending on the complexity of each project
Responsibilities Include:
1. Partner with R&D, QA, Global Technical Operations, Business Units and others to contribute to China regulatory CMC strategies for submissions and product related activities.
2. Identify the required documentation for CMC submissions and negotiate the delivery of approved technical source data and documents in accordance with project timelines.
3. Write or compile high-quality CMC documents during product registration, contribute to CMC regulatory strategies, assure technical congruency and regulatory compliance by meeting agreed submission deadlines.
4. Review post-approval changes (change controls) and assess the regulatory impact on affected registrations. Contribute to regulatory strategies and coordinate filings (e.g. NDA supplements, Variations and Renewals), as appropriate.
5. Compile responses to local Chinese regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines.
6. Communicate information and present status updates on product/project activities to key internal/external stakeholders of various levels.
7. May represent group and provide regulatory advice at e.g. joint company/trade association initiatives, regulatory agency meetings etc. (as appropriate), seminars, workshops, etc.
8. Assists in development of best practices for Regulatory Affairs processes.
9. Maintains and archives regulatory documentation (as appropriate).
10. Coordinates small work groups and participates on providing direction.

RA CMC Specialist
? A Minimum of a B.S. in relevant technical or scientific field is required.
? A minimum of 2 - 5 years relevant CMC experience including preparation of CMC sections for Health Authority filings (Modules 2 and 3, CTD, e-CTD) and maintenance.
? Good Experience in China CMC-writing & local dossier technical requirements would be beneficial.
? Working knowledge of regulatory requirements for various drug dosage forms including solids, semi-solids and solutions is required.
? Familiarity with consumer product categories (drugs, cosmetics or devices).
? Experience with devices and combination products may be beneficial.
? Experience with EMEA, US, Canadia & other international submissions is an advantage.
? Technical/science-based background (QA, Manufacturing, Laboratory, Plant, etc.) is preferred.

万宝盛华大中华有限公司，1997年服务启航于香港和台湾。迄今服务已覆盖上海、北京、广州、深圳、香港及台湾等逾20座直营城市，总部坐标上海。我们的大股东万宝盛华全球（ManpowerGroup Inc. NYSE:***）是全球人力资源解决方案领导者，拥有超过70年历史，服务网络覆盖80多个国家和地区。万宝盛华大中华深耕本土20余年，服务网络触达两岸三地150余城市，服务企业逾两万家。2015年，万宝盛华大中华战略联盟中信产业基金，加速布局本土战略。2019年7月10日，万宝盛华大中华股份有限公司成功登陆港交所。公司始终致力于释放人才的发展潜能，凭借灵活用工、人才寻猎、招聘流程外包、管理咨询及培训发展等人力资源综合解决方案，广受业界赞誉，屡次荣膺“亚太人力资源领军企业”。