GILEAD
Associate Director, Regulatory Affairs - Oncology
GILEAD, San Mateo, California, United States, 94409
Regulatory Affairs Manager
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 relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. 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: Responsible for preparing and/or overseeing the preparation of technically complex regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. May direct others in accomplishing Corporate Objectives. Responsible for submitting complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories. Responsible for preparation of the Company Core Data Sheets (CCDS) for assigned products. Contributes to the regulatory review of draft Product Company Core Safety Information (CCSI) and ensures updates to the CCDS or CCSI are implemented. Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license. Provides strategic regulatory advice as appropriate. Maintains knowledge of regulatory requirements up to date and communicate changes in regulatory information to project teams and senior management in a timely manner. Initiates local process improvements and contributes to local and / or global process improvements, which have a significant impact for the Regulatory Affairs Department or other departments. Plans, schedules and arranges own activities and those of direct reports (if applicable). Excellent verbal and written communication skills and interpersonal skills are required. Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities. May be required to assume a leadership role in updating and preparing the Company for minor changes in legislation in assigned territories and of actively participating in a broader cross functional team for implementation of major changes. Must be capable of leading a small team in preparation of submissions and maintenance of licenses. Work is performed with no immediate direction from a senior Regulatory Affairs professional. Is recognized as a knowledgeable resource for Regulatory Advice in other departments. Demonstrated ability to act as primary Company contact with Regulatory Authorities. Previous people management experience is desirable. Direct experience working with Regulatory Authorities in assigned territories is required. Experience representing Regulatory Affairs on submission teams is mandatory and on Project Teams is desirable. The salary range for this position is: Bay Area: $182,070.00 - $235,620.00. Other US Locations: $165,495.00 - $214,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
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 relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. 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: Responsible for preparing and/or overseeing the preparation of technically complex regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. May direct others in accomplishing Corporate Objectives. Responsible for submitting complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories. Responsible for preparation of the Company Core Data Sheets (CCDS) for assigned products. Contributes to the regulatory review of draft Product Company Core Safety Information (CCSI) and ensures updates to the CCDS or CCSI are implemented. Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license. Provides strategic regulatory advice as appropriate. Maintains knowledge of regulatory requirements up to date and communicate changes in regulatory information to project teams and senior management in a timely manner. Initiates local process improvements and contributes to local and / or global process improvements, which have a significant impact for the Regulatory Affairs Department or other departments. Plans, schedules and arranges own activities and those of direct reports (if applicable). Excellent verbal and written communication skills and interpersonal skills are required. Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities. May be required to assume a leadership role in updating and preparing the Company for minor changes in legislation in assigned territories and of actively participating in a broader cross functional team for implementation of major changes. Must be capable of leading a small team in preparation of submissions and maintenance of licenses. Work is performed with no immediate direction from a senior Regulatory Affairs professional. Is recognized as a knowledgeable resource for Regulatory Advice in other departments. Demonstrated ability to act as primary Company contact with Regulatory Authorities. Previous people management experience is desirable. Direct experience working with Regulatory Authorities in assigned territories is required. Experience representing Regulatory Affairs on submission teams is mandatory and on Project Teams is desirable. The salary range for this position is: Bay Area: $182,070.00 - $235,620.00. Other US Locations: $165,495.00 - $214,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.