For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals. Job Description Specific Responsibilities and skills for Position * This position will report to the Head of Regulatory Affairs Korea, based in Korea and provide regulatory support on license management and product development program in Korea. Essential Duties and Job Functions * Being the regulatory lead for Korea, the professional will fulfill regulatory responsibilities including but not limited to: Independently lead and manage regulatory submissions, including CTA and NDA filings and obtain timely approval Maintain product registration certificates by timely submission and... approval of variations and renewals Act as main contact and manage negotiations with regulatory authorities Act as a consultant to local affiliate, regional, international or global RA teams on local regulatory matters Provide regulatory strategic input for product development program to drive rapid product registration approvals Prepare regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with regional requirements and scientific and company policies and procedures. 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. Ensure regulatory/legal compliance of regulatory activities Provide regulatory support to ensure compliance on business practice, e.g. promotional material review and approval, development of system / SOPs as necessary Maintain RA database, records and archives regulatory documentation Knowledge, Experience and Skills * University graduate in Science or Pharmacy. Minimum 5 years of relevant experience in Regulatory Affairs for Korea. Experience in oncology & biologic products is preferred. Excellent organization skills, strong attention to detail and ability to work on a number of projects with tight timelines are required. Excellent verbal and written communication skills and interpersonal skills are required. Good team player and excellent cross-function collaboration. In-depth knowledge of regulatory requirements, including local and international requirements. Recognized as a knowledgeable resource within the department. Work is performed under minimal supervision of a senior Regulatory Affairs professional. For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. The health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority. The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation
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