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.