Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Taipei

Description

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


Job Description

*Essential Duties and Job Functions: 


• Responsible for maintaining the necessary licenses.
• Responsible for preparing regulatory submissions which require interactions with other functions for investigational and commercial products in line with ICH requirements, Taiwan requirements and scientific and company policies and procedures.
• Responsible for submissions which may include marketing authorizations, variations, and license maintenance.

• 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/SOPs as necessary.
• Responsible for PMF registration & follow up in Taiwan.
• Responsible for quality assurance activities in Taiwan.

• Support for drug safety activities as needed.

• Responsible for IND submission and archives related document.


*Knowledge, Experience and Skills:  

• University graduate in Science or Pharmacy.

• Minimum 8 years of relevant experience in Regulatory Affairs or RA related for Taiwan.

• Excellent organization skills and ability to work on a number of projects with tight timelines is required.

• Excellent verbal and written communication skills and interpersonal skills are required.

• General understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories is required.

• Recognized as a knowledgeable resource within the department on limited topics.

• Work is performed under minimal supervision of a Regulatory Affairs professional.


*Academic Level:  
Masters perfered


*Specific Responsibilities and skills for Position:  

This position will report to the RA Associate Director based in Taiwan and provide regulatory support on new product development program for rapid product pipeline expansion in Taiwan.


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

About the company

Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff of more than 8,000 people is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.

Our scientific focus has resulted in 23 marketed products that are benefiting millions of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.

Today, Gilead's research and development effort is the largest it has ever been evaluating compounds with the potential to become the next generation of innovative therapies for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases and cardiovascular conditions. The commercial success of Gilead's portfolio of 23 products has provided the company with the vital resources to support the development of new therapeutic advancements.

Working at Gilead provides you with plenty of opportunities for career advancement in a growing and agile environment while working with highly respected teams.

We would like to invite you to be a part of an organization that has helped millions of people around the world live healthier and more fulfilling lives

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