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Regulatory Submission Management Associate Manager -Beijing

Your role:

  1. Lead submission taskforce on key projects
  2. Set up routine meetings to ensure adequate progress on submission preparation within submission timeline.  Responsible to prepare clear meeting minutes.
  3. Create maintain and track submission project plan and digital dossiers for initial submissions, ensuring timely and efficient dossier creation, compilation and submission to HA.
  4. Accountable for system relate entries and management.
  5. Oversight regulatory project management on budget demand for GRA deliverables on development portfolio.
  6. Visible face for system related topics in country
  7. Lead to develop, review and learn SOPs or guidance manuals.
  8. Carry out any other tasks as required by the function to achieve its mission and objectives
     

Who you are

-     Bachelor’s degree in a Life Science related discipline 

-     Fluent in English

-     Minimum of 4 years regulatory or related experience in the pharmaceutical or biotech industry.

-     GRA Ops experience

-     Submission experience to HA in China

-     Understanding of local regulations, guidelines and requirements

-     Submission experience in Taiwan and / or Hong Kong would be a benefit

-     Good communication / collaboration skills

-     MNC experience preferred

 

 

HR95601

Functional area: Regulatory & Medical affairs

Job Requisition ID:  192110
Location:  Beijing - all
Career Level:  D - Professional (4-9 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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