Sr Manager, Regulatory Affairs

Sr Manager, Regulatory Affairs
China - Beijing

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Job Summary:
- Support RA director for regulatory activities of CTA, NDA, variations and maintenance

Key Activities:
- Support RA director for applying, obtaining and maintaining regulatory approvals for import and local products, including CTA, NDA, Manufacturing License, Variations
- Arrange and follow up document translation, verification, copying and printing, filing, and archiving of regulatory dossier
- Coordinate and follow up QC testing at NIFDC & PFDC, including shipment of reagents and samples, coordinate communication with headquarter team
- Follow up review status with CDE
- Arrange and support meetings with agencies when necessary

- Fulfill local DSUR submission responsibilities.

- Maintain RA database, records and archives regulatory documentation.

- Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses and follow up on new packaging implementation.

- Provide regulatory support to ensure compliance on business practice, e.g. development of system/local SOPs as necessary.

- Collect regulatory intelligence information and assess regulatory policy

Basic Qualifications
- Minimum 6~12 years of relevant experience in Regulatory Affairs
Preferred Qualifications
- Experience in regulatory works
- Fluent in English
- Study background in pharmaceutical / medicinal / biological
- Basic knowledge of regulatory requirements for medicinal products
- Communication Skills: Oral and Written
- Team Work

/

• HIV
  
  
  
• CTANDA
  
  
  
• CTANDA
• NIFDCPFDC
• CDE
• DSUR
• RA
• /SOP
• 
  
  
  
• 6-12
  
  
• //

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/China---Beijing/Sr-Manager--Regulatory-Affairs_R0017076





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