北京招聘

职位描述：

JD – Head of Regulatory Management, Greater China, Korea, Japan

Job Objective:

This position will manage regulatory affairs for Merck Life Science (LS) business in Greater China, Korea, Japan with effective management and strategy development. Drive, manage and coordinate regulatory projects in Greater China, Korea, Japan, including managing thought leadership initiatives, product registrations, supporting business regulatory needs and customer training/requests. Facilitate and maintain excellent working relationship with government officials and customers.

Job Responsibilities:

This job will be based in Shanghai.

• Effective drive and manage regulatory strategy for Merck Life Science (LS) products and services in Greater China, Korea, Japan. Cover the areas of pharm/food testing, environmental testing, APIs, pharmaceutical excipients, food additives, aseptic processing, single-use, medical devices, IVDs, equipment/instrument, biologics and animal derived materials, reference standards.


• Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of Merck Life Science interests.


• Safeguard Merck strategic interests and objectives in arising guidance, standards and regulation.


• Monitor and report on changes of relevant regulatory and compliance environment with impact with Merck Life Science business. Analyze available regulatory and compliance information.


• Effective coordination of strategic activities with Merck subject matter experts, local regulatory bodies and industry associations.


• Secure flow of information from/to authorities, industry associations and Merck Life Science organization.


• Training and support to internal stakeholders, external customers and relevant regulatory bodies.


• Training to educate local marketing/sales colleagues about new regulatory trends and developments that drive our value proposition.


• Definition of processes to implement upcoming regulatory needs and requirements.


• Closely work with local regulatory surveillance & advocacy team and regulatory subject matter experts to link the local advocacy activities with global/regional advocacy activities.


• Drive, manage and coordinate registration / notification / listing activities. Ensure the correctness and timeliness of these activities, interim follow-up change management and final outcome. Ensure tracking, maintenance and reporting of registration / notification / listing status.


• Provide regulatory guidance in risk assessment, identify regulatory impact to Merck Life Science and provide regulatory recommendations to mitigate potential risk.


• Take active role to represent company in delicate or risk potential matters with regulatory agencies, inspectors and trade associations.


• Provide regulatory support to marketing, sales and customers via consultation, seminars and training events.


• Manage regulatory team in Greater China, Korea, and Japan.

Qualifications:

Education and Languages:

• Technical degree required, pharmaceutical, bioscience, chemical analysis related science discipline.


• Fluent in Chinese and English (verbal and written) is required.

Professional Skills and Experience:

• Experience of minimum 12 years in pharmaceutical / life science / chemical industry, extensive knowledge in pharm/food testing, biopharmaceutical, pharmaceutical materials.


• Broad and extensive regulatory knowledge of laws and regulations in pharmaceuticals, food and environmental testing. Proven knowledge of regulations in medical devices/IVDs and animal derived materials. Familiar with US and European regulations and industrial regulatory guidelines in above mentioned areas.


• Experience working in a global, matrix environment.

Personal Skills and Competencies:

• Excellent interpersonal, presentation, listening and communication skills.


• Strong organizational and time management skills.


• Ability to manage multiple priorities and deliver accurate outcomes.


• Ability to indirectly influence other organizations and cultures.


• Ability to train and educate others.


• Effective management by influence.


• Good listening skills with the ability to analyze and respond to given situations quickly and effectively.


• Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.


• Experience in thought leadership.


• Ability to work in multi-cultural teams.


• Proficient in MS Office Software (Word, Excel, PowerPoint, Project).


• Able to travel.

举报 分享

Merck – Living Innovation
默克 – 创新引领生活

默克是一家全球领先的医药与化工公司，以创新和高科技优质产品闻名世界。

默克在全球66个国家与地区拥有约38,000名员工，致力于改善患者的生活质量，助力客户实现长远的成功和迎接全球化挑战。

默克旗下四大业务分支——默克雪兰诺、消费者健康、功能性材料和默克密理博——2012年总收入达112亿欧元。

默克是全球历史最悠久的医药与化工公司。自1668年起，默克就成为了创新、成功和负责任的企业家精神的代名词。默克家族作为公司的创始人至今仍持有默克大部分的股份。

我们是默克，正根正源，在全球拥有“默克”这一名称和品牌的所有权。唯一的例外是在美国和加拿大，我们使用“EMD”的名称。
Merck – Living Innovation

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors.
Around 38,000 employees work in 66 countries to improve the quality of life for patients, to further the success of our customers and to help meet global challenges.
We generated total revenues of