Manager, Regulatory Affairs (1 yr Fixed-Term Contract)

Location
Foster City
Salary
See job description.
Posted
November 18 2020
Ref
R0015966
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager


Manager, Regulatory Affairs (1 yr Fixed-Term Contract)
South Korea - Seoul

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


Responsibilities
  • Prepare regulatory applications and obtain timely submissions and approvals of IND, NDA, and ODD as required for investigational and commercial products (IND and NDA) in Korea with compliance to local requirements and company policies and procedures.
  • Set up registration strategy and timeline according to the regulations and business needs
  • Provide the central functions of proper guidance and supports as a local expert for the local requirements, e.g. bridging data
  • Responsible for submissions which include regular reports, amendments/variations, supplements and license renewals to marketing authorization applications and clinical trial applications for Korea.
  • Provide relevant regulatory information and insight to other departments and collaborate with other divisions for related works based on regulatory environment including comparator intelligence.
  • Liaise with the concerned departments and the health authorities to manage the regulatory projects with compliance to company policies and procedures
  • Ensure product packaging and associated information including promotional materials are updated and maintained in accordance with the product licenses.
  • Provide regulatory support to ensure compliance on business practice including being trained with SOPs as required


Qualifications
  • 4-6 years of working experience in RA with strong technical knowledge for NDA, IND and variation
  • Good command of English
  • Excellent organization skills and ability to work on a number of projects with tight timelines is required.


Gilead Core Values
  • Integrity (doing what's right)
  • Inclusion (encouraging diversity)
  • Teamwork (working together)
  • Excellence (being your best)
  • Accountability (taking personal responsibility)



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/South-Korea---Seoul/Manager--Regulatory-Affairs_R0015966-1





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