MAIN OBJECTIVE OF THIS POSITION
设立该职务的基本目的
? To be fully responsible for
all the registration and regulatory activities of assigned brand(s) with the
supervision from Product Registration Manager, and assist to regulatory
project when necessary
MAIN RESPONSIBILITIES OF THIS POSITION
该职务的主要职责
? To be responsible for the registration general work for assigned brand(s) with supervision from Product Registration Manager, including all registration
submission actives, regulatory input according to business requirement, etc.
? To be responsible of registration material and document preparation for registration
general work to make
sure these materials comply with internal SOPs and external regulation, and
deliver HPs within targeted timeline
? To communicate with CFDA, testing agencies and other registration related authorities if necessary to guarantee all regulatory
activities fully comply with China regulations and requirement
? To follow registration process (system and SOPs), and update
registration status with all functions (MKT, HQ RA, HQ Safety, Supply chain) actively
and routinely to make their good awareness of HP timeline and registration
risk and issues
? Good documentation for all
registration materials
? Identify potential risk through
daily work, and input with regulatory aspect to help brand set up mitigation
plan
? To assist to review market
claim material especially on the content of label and insert;
? Support Product Registration Manager
on other business requirement and regulatory projects
MAIN KPIs OF THIS POSITION
该职务的主要业绩指标
? HP successful
passing rate; Lead-time
? HP# per year
? System on-time and accurate
update
? Documentation
PRINCIPAL COMPETENCIES, SKILLS AND BACKGROUND
该职务所需的主要技能及相关背景
Key Competence:
- Bachelor degree or above (Pharmacy, Medical, Chemical, Toxicology or other related
education background)
- At least 2 years' experience on cosmetics products registration; Familiar with China related cosmetics regulations.
- Patient and willing to go to details
- Good team player
- Proper communication skills
- Well organized
Technical Skills:
- Fluent in English (both written & speaking)
- Self-sufficiency, organizational ability, rigorous, accuracy
- Scientific-based: Pharmacy, Medical, Chemical, Toxicology or other related education background
KEY CONTACTS AND RELATIONS / 与该职务相关的人或组织
(INCLUDED BUT NOT LIMITED)
Internal / MKT, HQ RA, HQ Safety, HQ planning, Local
supply chain
Externat / CFDA, Testing agencies, Registration agency
职能类别: 合规主管/专员 药品注册
联系方式
上班地址:上海南京西路1266号恒隆广场
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