Regulatory Submission Management Associate Manager -Beijing

Posted 15 May 2019

Beijing - all, Beijing - China

Req Id 192110

Details

A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


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


What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
 

Curious? Apply and find more information at https://jobs.vibrantm.com
 

Apply Now

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