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Head of Regulatory Management Great China

This position is based in Shanghai or Beijing.

 

Your role:

 

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

 

  • Effective manage regulatory pathway for Life Science (LS) products and services in Great China, cover the areas of biopharma processing, pharm & food testing, pharm & food materials (APIs, pharmaceutical excipients, food additives), medical devices, IVDs, etc.
  • Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of Life Science interests. Safeguard company strategic interests and objectives in arising guidance, standards and regulation.
  • Monitor and report on changes of relevant regulatory and compliance environment with impact with the Life Science business. Analyze available regulatory and compliance information.
  • Effective coordination of strategic activities with the company subject matter experts, local regulatory bodies and industry associations. Secure flow of information from/to authorities, industry associations and the Life Science organization.
  • Training and support to internal stakeholders, external customers and relevant regulatory bodies. Provide relevant 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 global/regional 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 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.

 

Who you are:

 

Education and Languages: 

  • Master in life sciences or related science / engineering background with a strong emphasis in pharmaceuticals & biotech.
  • Fluent in Chinese native & English (verbal and written) is required.

 

Professional Skills and Experience:

  • Experience of minimum 12 years in pharmaceutical & biotech Industry, extensive knowledge in pharmaceutical and life science products.
  • Broad and extensive regulatory knowledge of China laws and regulations of NMPA and CFSA. Familiar with US and European regulations and industrial regulatory guidelines in above mentioned areas.
  • Experience working in a global, matrix environment. Ability to work in multi-cultural teams.
  • People management experience to lead a team in complex and fast changing environment. 
  • Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.

 

Personal Skills and Competencies:

 

  • Strong organizational and time management skills. Effective management by influence.
  • Ability to manage multiple priorities and deliver accurate outcomes.
  • Ability to indirectly influence other organizations and cultures.
  • Ability to train and educate others.
  • Experience in thought leadership.
  • Proficient in MS Office Software (Word, Excel, PowerPoint, Project).
  • Be able to travel.

 

HR: 89829

Functional Area: Regulatory & Medical Affairs

 

 

Job Requisition ID:  201300
Location:  Shanghai - all
Career Level:  E - Professional (10+ years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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