Gilead Sciences, Inc.
Associate Director, Regulatory Affairs - Oncology
Gilead Sciences, Inc., Foster City, California, United States, 94420
Associate Director, Regulatory Affairs - Oncology
Job Description
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working to develop therapies that help improve lives and ensure access to these therapies globally. Our mission requires collaboration, determination and a relentless drive to make a difference. We are seeking a capable regulatory affairs leader to contribute to the discovery and development of life-changing scientific innovations. As a people leader at Gilead and Kite, you will help create an inclusive culture where every employee feels developed and empowered to fulfil their aspirations. Job Description Specific Education & Experience Requirements: 10+ years of experience in Regulatory Affairs or other relevant industry experience. Degree in a scientific field is preferred. Specific Job Responsibilities: Prepare and/or oversee technically complex regulatory submissions requiring extensive cross-functional interaction for investigational and commercial products in assigned territories, in line with ICH, regional requirements and company policies. May direct others in accomplishing Corporate Objectives. Submit complex regulatory documents including safety reports, amendments, supplements and license renewals for clinical trial applications and marketing authorizations (INDs/CTAs and NDAs/MAAs) in assigned territories. Prepare Company Core Data Sheets (CCDS) for assigned products and contribute to regulatory review of draft Core Safety Information (CCSI), ensuring updates are implemented. Ensure product packaging and related information are updated and maintained per product license. Provide strategic regulatory advice as appropriate and maintain up-to-date knowledge of regulatory requirements; communicate changes to project teams and senior management in a timely manner. Initiate local and global process improvements with significant impact for Regulatory Affairs or other departments. Plan, schedule and manage own activities and, if applicable, the activities of direct reports. Demonstrate excellent verbal and written communication and interpersonal skills; possess in-depth knowledge of ICH and regional regulatory requirements and current global/regional trends. Develop and implement regulatory strategy and manage complex negotiations with Regulatory Authorities. Lead or participate in cross-functional teams for major regulatory changes; may lead a small team in submission preparation and license maintenance. Work with minimal direction from senior Regulatory Affairs professionals and serve as a knowledgeable resource for Regulatory Advice in other departments. Act as primary Company contact with Regulatory Authorities; direct regulatory experience in assigned territories is required and experience representing Regulatory Affairs on submission teams is mandatory (Project Teams desirable). Salary Range The salary range for this position is: Bay Area: $182,070.00 - $235,620.00 Other US Locations: $165,495.00 - $214,170.00 Additional Information Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for discretionary bonuses, stock-based incentives, paid time off, and a comprehensive benefits package (medical, dental, vision, life insurance, etc.). Benefits information is available at the Gilead careers site. Equal Employment Opportunity Gilead Sciences Inc. is an equal opportunity employer. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other protected characteristics as required by law. Application Note For current Gilead employees and contractors, please apply via the Internal Career Opportunities portal in Workday. Requisition ID: R0047092. Full-Time. Job Level: Associate Director.
#J-18808-Ljbffr
Job Description
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working to develop therapies that help improve lives and ensure access to these therapies globally. Our mission requires collaboration, determination and a relentless drive to make a difference. We are seeking a capable regulatory affairs leader to contribute to the discovery and development of life-changing scientific innovations. As a people leader at Gilead and Kite, you will help create an inclusive culture where every employee feels developed and empowered to fulfil their aspirations. Job Description Specific Education & Experience Requirements: 10+ years of experience in Regulatory Affairs or other relevant industry experience. Degree in a scientific field is preferred. Specific Job Responsibilities: Prepare and/or oversee technically complex regulatory submissions requiring extensive cross-functional interaction for investigational and commercial products in assigned territories, in line with ICH, regional requirements and company policies. May direct others in accomplishing Corporate Objectives. Submit complex regulatory documents including safety reports, amendments, supplements and license renewals for clinical trial applications and marketing authorizations (INDs/CTAs and NDAs/MAAs) in assigned territories. Prepare Company Core Data Sheets (CCDS) for assigned products and contribute to regulatory review of draft Core Safety Information (CCSI), ensuring updates are implemented. Ensure product packaging and related information are updated and maintained per product license. Provide strategic regulatory advice as appropriate and maintain up-to-date knowledge of regulatory requirements; communicate changes to project teams and senior management in a timely manner. Initiate local and global process improvements with significant impact for Regulatory Affairs or other departments. Plan, schedule and manage own activities and, if applicable, the activities of direct reports. Demonstrate excellent verbal and written communication and interpersonal skills; possess in-depth knowledge of ICH and regional regulatory requirements and current global/regional trends. Develop and implement regulatory strategy and manage complex negotiations with Regulatory Authorities. Lead or participate in cross-functional teams for major regulatory changes; may lead a small team in submission preparation and license maintenance. Work with minimal direction from senior Regulatory Affairs professionals and serve as a knowledgeable resource for Regulatory Advice in other departments. Act as primary Company contact with Regulatory Authorities; direct regulatory experience in assigned territories is required and experience representing Regulatory Affairs on submission teams is mandatory (Project Teams desirable). Salary Range The salary range for this position is: Bay Area: $182,070.00 - $235,620.00 Other US Locations: $165,495.00 - $214,170.00 Additional Information Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for discretionary bonuses, stock-based incentives, paid time off, and a comprehensive benefits package (medical, dental, vision, life insurance, etc.). Benefits information is available at the Gilead careers site. Equal Employment Opportunity Gilead Sciences Inc. is an equal opportunity employer. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other protected characteristics as required by law. Application Note For current Gilead employees and contractors, please apply via the Internal Career Opportunities portal in Workday. Requisition ID: R0047092. Full-Time. Job Level: Associate Director.
#J-18808-Ljbffr