衡阳招聘

Responsibilities :

1. Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets

2. Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions,

3. Works with a cross functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch.

4. Assesses changes in existing products to and determines the need for new / revised licenses or registrations.

5. Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.

6. Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.

7. Contributes to writing and editing technical documents

8. Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions

9. Understands and applies regulatory requirements and their impacts for submissions

11. Ensures compliance with pre- and post-market product approval requirements

10. Supports regulatory inspections as required.

11. Assesses adverse events and field actions for reportability to regulatory authorities and prepares and submits reportable events and recalls in a timely manner to regulatory authorities, as per country regulations. 12. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager

Qualifications :

? Bachelor's Degree or a minimum of 3years work experience.

? Minimum of 1 year experience working in a regulated industry

? Where required by law the Technical Responsible will meet required qualifications in terms of education, certifications and experience (for example, Pharmacist in Brazil).

? Ability to communicate effectively in English (both written and oral).

? Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

北京外企德科人力资源服务上海有限公司（简称 FESCO Adecco 外企德科）是中国人力资源服务行业具竞争力和品牌价值的FESCO与全球人力资源服务行业领航者Adecco成立的一家中外合资人力资源服务企业，为企业及个人提供业务外包、人事服务、招聘猎头和员工福利等相关人力资源解决方案。

成立于1979年，FESCO拥有悠久的人力资源专业化服务历史、丰富的市场经验以及完备的服务资质，是中国人力资源服务行业的领跑者，Adecco则是全球人力资源行业的巨头，服务网络遍布全球60多个国家和地区。FESCO Adecco成立后，双方通过优势互补，整合了客户资源，依托全球化的资源和服务平台，融合本土网络优势，扩大了业务范围，为客户提供全方位的业务流程外包（BPO）、财务外包与薪酬管理、人事委托/人事派遣、全球化派遣、人才招聘/RPO相关服务、健康福利与弹性福利等人力资源解决方案。合资后的FESCO Adecco飞速发展，并且在浙江、重庆、深圳、苏州设立了分支机构。目前，FESCO Adecco在中国每天服务达100万名员工，服务客户近12,000家。

FESCO Adecco致力于成为***的人力资源全面解决方案提供商，成为客户最值得信赖的人力资源合作伙伴。为客户打开通向国际市场及创新型人力资源服务模式的大门，推动中国乃至全球的人力资源外包产业的健康发展。