Gilead Sciences, Inc.
Senior Associate, CMC Regulatory Affairs-Biologics
Gilead Sciences, Inc., Foster City, California, United States, 94420
Senior Associate, CMC Regulatory Affairs-Biologics
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.Job Description:Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for investigational and marketed products for US, Asia and LATAM in line with ICH requirements, regional requirements and scientific and company policies and procedures.Responsible for routine clinical and commercial labeling approvals and changes, protocol reviews, drug listing review and ensuring product packaging and associated information is updated and maintained in accordance with the product license.Develop and maintain knowledge of regulatory requirements independently and with line manager.Assess change controls for regional regulatory impact and record assessment using a variety of internal systems.Contribute to local process improvements, which have an impact on the working of the RA CMC function or other departments.Work cross-functionally within a matrixed organization.Primarily plans, schedules and arranges own activities in alignment with project goals and deadlines.Must be capable of leading a small team in preparation of regional submissions.Must work well under deadlines and have excellent attention to detail. Work is performed under limited direction of a senior Regulatory Affairs professional.Minimum Qualifications:A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 6 years with a BA/BS, or at least 4 years with an MA/MS.Relevant Regulatory CMC submission experience.Knowledge of global CMC regulatory landscape.Excellent verbal and written communication skills and interpersonal skills are required.Strong computer and organizational skills required.The salary range for this position is: $124,015.00 - $160,490.00. 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, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics.
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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.Job Description:Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for investigational and marketed products for US, Asia and LATAM in line with ICH requirements, regional requirements and scientific and company policies and procedures.Responsible for routine clinical and commercial labeling approvals and changes, protocol reviews, drug listing review and ensuring product packaging and associated information is updated and maintained in accordance with the product license.Develop and maintain knowledge of regulatory requirements independently and with line manager.Assess change controls for regional regulatory impact and record assessment using a variety of internal systems.Contribute to local process improvements, which have an impact on the working of the RA CMC function or other departments.Work cross-functionally within a matrixed organization.Primarily plans, schedules and arranges own activities in alignment with project goals and deadlines.Must be capable of leading a small team in preparation of regional submissions.Must work well under deadlines and have excellent attention to detail. Work is performed under limited direction of a senior Regulatory Affairs professional.Minimum Qualifications:A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 6 years with a BA/BS, or at least 4 years with an MA/MS.Relevant Regulatory CMC submission experience.Knowledge of global CMC regulatory landscape.Excellent verbal and written communication skills and interpersonal skills are required.Strong computer and organizational skills required.The salary range for this position is: $124,015.00 - $160,490.00. 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, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics.
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