Sr. Regulatory Affairs
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
Responsibilities:
Be responsible for the registrations of imported drug. Including but not limited to the good communications with NMPA CDE and other authority registration documents preparation performing the test documents submissions and follow up of NMPA until get the approval.
Timely documents archiving. Other tasks if needed.
Minimum Qualifications:
Bachelor degree At least 2-3 years experience on imported drug registration
Good at written and oral English Preferred
Qualifications:
Medical education background
The experience on all of API ANDA IND and other type registration is helpful
Good communications skill
Required Experience:
Senior IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
