北京招聘

Position Purpose:

The Head Regulatory Affairs China provides leadership, strategic direction and managerial oversight to the CSL Regulatory Affairs team in china.

Accountable for defining and executing innovative regulatory strategies for CSL products and development programs in China, including those from our Wuhan facility, as well as developing and maintaining strong working relationships with HA in China.

Provides direction to senior leadership and teams on emerging trends, regulations and changes, enabling proactive approach and planning to future business requirements.

Provides senior leadership, mentorship and training within regulatory organization.

Represents regulatory affairs on key internal and external committees relevant to China activities

Main Responsibilities and Accountabilities:

1 Leading the organization in development and execution of regulatory strategy for CSL’s new product development and registration, and maintenance of registered products in China.

2 Responsible for performing regulatory procedures including, but not limited to, clinical trial application, marketing applications, change management applications, license renewals, agency meetings, Periodic Safety Update Reports (PSUR), required reporting activities related to clinical or marketing applications/approvals.

· Represent Regulatory Affairs in cross-functional teams (e.g., Core Project Teams)

· Lead and contribute to regulatory strategy development, working with cross-functional teams

· Lead and contribute to the compilation of high-quality documentation for submissions and correspondences with state or provincial regulatory authorities

3 Develop and maintain effective working relationship with health authorities in China, demonstrated by high quality communication and effective use of negotiation/influence skills to achieve positive outcomes for CSL.

4 Maintain knowledge of the regulatory environment by reviewing and implementing current policies/practices issued by the Health Authorities in China.

5 Provide input to budgets and resource plans; monitor activities and progress to ensure strategic objectives are achieved.

6 Create and build confidence by establishing an effective regulatory affairs team in China as an informed, capable, knowledgeable and accessible resource to CSL.

· Build productive team and drive their performance.

· Responsible for coaching and development of team members.

· Partner with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions.

· Conduct annual performance evaluations for direct reports.

· Arrange for training and orientation of new regulatory affairs staff in accordance with CSLs global, regional and local SOPs

Position Qualifications and Experience Requirements:

Education： A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate degree Experience

• At minimum 12 years’ experience in the pharmaceutical industry, preferably in Biologics in the areas R&D, Regulatory Affairs
• At least 8 years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience.
• Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and regional Regulatory Authorities.
• Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product.
• Understanding of the principles of GxPs.
• Strategic and tactical thinking ability, complemented by a “hands on” operational approach and business planning orientation.
• Ability to identify the ‘big picture’ and opportunities/major issues and link day to day tasks with long term goals.
• Demonstrated ability to lead and influence a team. Keeps a team focused to deliver according to agreed milestones, can inspire and motivate while providing corrective feed-back, if required.
• Demonstrated ability to deal with rapid change.
• Demonstrated sound judgment and flexible approach to managing situations.
• Customer service focus.

Competencies

• Strong ethics and integrity

• Self-motivated, pro-active and strategically focused.

• Highly effective communicator with written, verbal and presentation skills.

  • Fluent in reading, writing, and speaking English and Chinese (Mandarin)

• Demonstrated ability to successfully manage and lead a diverse group of people with excellent interpersonal skills in a multicultural environment

• Planning, organizing and time management skills.

• Demonstrated ability to work across multiple disciplines.

• Ability to operate with minimal to no supervision and to establish professional, credible relationships within CSL Behring and externally.

• Demonstrated ability to develop constructive and effective relationships with peers and management.

Level of supervision: provides recommendations and solutions to supervisor, manages projects and/or staff with minimal supervision.

CSL集团
CSL(Commonwealth Serum Laboratories的缩写）于1916年成立于澳大利亚，旨在服务因战争而孤立的国家的健康需求。1991年，CSL公司兼并重组后于1994年在澳大利亚证券交易所挂牌上市。此后，CSL成功收购了多家公司，包括CSL Behring。目前CSL集团包括CSL Behring、CSL CSL Plasma、Seqirus 及Research & Development。在过去近100年的历史中，CSL向全球提供疫苗、血浆制品和科技研发等，专注于拯救及改善人类的生命。

CSL Behring
CSL Behring(中文名称杰特贝林)的公司发展历史最早可以追溯到Emil von Behring博士。这位来自德国的医生作为血清疗法的创新者，于1901年赢得了首个诺贝尔生理学和医学奖，而双方的成功合作缔造了当今持续创新的全球公司CSL。CSL产品名称中的“贝林(英文名称‘Behring’)”就是取自Emil von Behring博士的名字，用以纪念他为全人类的健康做出的卓越贡献。
CSL Behring的总部位于美国宾西法尼亚州，全球三大制造工厂分别位于美国的伊利诺州、瑞士的伯尔尼和德国马堡，而销售和配送中心则遍布全球19个国家，拥有并运营世界上最先进的血浆采集中心网络之一：CSL Plasma，是全球血浆蛋白生物治疗领域的领导者。

CSL 中国
杰特贝林（上海）医药信息咨询有限公司由CSL Behring公司直接管理,总部设在上海, 在北京、广州、成都、武汉设有分公司。主要产品由CSL Behring杰特贝林公司生产。贝林人血白蛋白自上世纪80年代进入中国,在中国已有20多年的临床安全使用记录。该产品在中国市场占有率排名领先（数据来自IMS Data）。

我们承诺将采用公正、透明的方式选拔和聘用人员，为所有员工提供平等的就业机会和安全健康的工作场所。我们倡导多元化的员工队伍，不论种族、性别、年龄、宗教、残疾和思维方式等的差别，让每一位员工都有机会将自己独特的能力、经验和特点融入到工作中，这有利于促进创新，增强核心竞争力，所以我们非常重视在内部各个级别上实现这种员工队伍的多元化。

CSL全体中国员工将继续秉承CSL集团价值观:卓越表现、创新、诚信、协作、以客户为中心，全心全意为广大客户提供优质的产品和服务，为挽救，康复并延长人类寿命做出我们的贡献！

公司网站：******************.au
电子邮箱：TAChina@cslbehring.com