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Regulatory Affairs Specialist

Job Responsibility

  • Responsible for animal by-products (Abp) and biologics special products regulatory compliance. Include but not limit to,
  • Coordinate documents preparation for import permit application, submit and follow up application process with local authority, make sure get import permit approval per plan. For example,
  1. Apply for Animal and Plant Import Permit for animal original media, serum and gelatin products, etc. and timely renew these permits;
  2. Apply for Sanitary Permit for biologics special products and timely renew these permits;
  3. Communicate with related local and global departments for information and document request, such as ManDec (Manufacturing Declaration) request, VC (Veterinary Certificate) request, etc.;
  • Keep good connection with related authorities (SHFDA, Customs, etc.).
  • Monitor Abp prohibition list and other Abp relevant regulation regularly, and inform internal stakeholders about regulations with impact to business.
  • Timely and effectively communication with global regulatory management team, Import & Export team and related business team regarding import check, import permit progress, customs clearance, regulatory risks with impact to business, work on mitigation plan to ensure compliance.
  • Support Life Science projects launched by Commercial.
  • Support labs on samples import/export.
  • Responsible for import permit application for trehalose and insulin products.
  • Miscellaneous administration works related with daily regulatory management.

 

Requirements:

  • Better with master’s degree of bioscience/biotechnology related background.
  • Best with related working experience of Animal by-Products and biologics (such as antibody, enzyme, protein, etc.) or regulatory working experience for >1 year. At least with working experience for 5 years.
  • Better with working experience in multinational company and familiar with SAP system.
  • Strong data compilation and multi-tasks management capability.
  • Good in learning and communication skills with teamwork manner.
  • Fluent in Chinese & English (read and written) is required.
  • Very good Microsoft skill.
Job Requisition ID:  194050
Location:  Shanghai - all
Career Level:  C - Professional (1-3 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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