Gilead Sciences, Inc.
Manager, Regulatory Affairs
Gilead Sciences, Inc., Foster City, California, United States, 94420
Overview
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.
Job Description Specific Education & Experience Requirements:
5+ years of experience in Regulatory Affairs or other relevant industry experience.
Degree in a scientific field is preferred.
Specific Job Responsibilities:
Responsible for preparing regulatory submissions which require interactions 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.
Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications (e.g. IND, CTAs), and marketing authorizations, original, marketing authorization applications for territories other than the US and EU and for contributing to preparation of US and EU marketing authorizations.
Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics.
Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling.
May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses.
Participate in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to moderately complex programs/projects.
Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge.
Initiates or contributes to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.
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.
Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories. Is recognized as a knowledgeable resource within the department on a range of topics.
Work is performed under minimal direction of a senior Regulatory Affairs professional.
Location & Salary
The salary range for this position is:
Bay Area: $146,540.00 - $189,640.00 Other US Locations: $133,195.00 - $172,370.00.
Benefits & Accessibility
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For more information about compensation, benefits and wellbeing, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Gilead is an equal opportunity employer. See Know Your Rights poster for more information. Applicants requiring accommodation in the job application process may contact ApplicantAccommodations@gilead.com.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
For Current Gilead Employees and Contractors Please apply via the Internal Career Opportunities portal in Workday.
Job Requisition ID R0047207
Full Time/Part Time: Full-Time
Job Level: Manager
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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.
Job Description Specific Education & Experience Requirements:
5+ years of experience in Regulatory Affairs or other relevant industry experience.
Degree in a scientific field is preferred.
Specific Job Responsibilities:
Responsible for preparing regulatory submissions which require interactions 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.
Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications (e.g. IND, CTAs), and marketing authorizations, original, marketing authorization applications for territories other than the US and EU and for contributing to preparation of US and EU marketing authorizations.
Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics.
Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling.
May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses.
Participate in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to moderately complex programs/projects.
Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge.
Initiates or contributes to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.
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.
Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories. Is recognized as a knowledgeable resource within the department on a range of topics.
Work is performed under minimal direction of a senior Regulatory Affairs professional.
Location & Salary
The salary range for this position is:
Bay Area: $146,540.00 - $189,640.00 Other US Locations: $133,195.00 - $172,370.00.
Benefits & Accessibility
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For more information about compensation, benefits and wellbeing, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Gilead is an equal opportunity employer. See Know Your Rights poster for more information. Applicants requiring accommodation in the job application process may contact ApplicantAccommodations@gilead.com.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
For Current Gilead Employees and Contractors Please apply via the Internal Career Opportunities portal in Workday.
Job Requisition ID R0047207
Full Time/Part Time: Full-Time
Job Level: Manager
#J-18808-Ljbffr