Gilead Sciences, Inc.
Senior Director - Analytical Regulatory Science
Gilead Sciences, Inc., Foster City, California, United States, 94420
Senior Director - Analytical Regulatory Science
Locations: United States - California - Foster CityTime Type: Full timePosted on: Vor 28 TagenJob Requisition ID: R0039437At 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 of 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 fulfill their aspirations. Join Gilead and help create possible, together.Job DescriptionThe Sr Director, Analytical Regulatory Science, is responsible for supervising a team of scientists, who collaborate with product development, manufacturing, and quality teams on the construction, documentation, and defense of the analytical control strategies in regulatory submissions preparation, review, and approval. By balancing analytical knowledge and evolving regulatory expectations with manufacturing and analytical flexibility, the incumbent will support “right first time” global approvals for CMC control strategies and maintain “right to operate” throughout the product lifecycle. In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. The incumbent will report directly to the Head of CMC Regulatory Affairs – Systems and Operations at Gilead.KEY RESPONSIBILITIESDrives and supervises team members to drive analytical control strategy development and justification in regulatory filings for projects throughout product lifecycle.Guides project teams on preparation of analytical filing content and participates in authoring and reviewing of complex submissions and responses to questions from health authorities.Exercises expertise in the interpretation and implementation of ICH and regional guidelines with the goal of right first-time approval of regulatory control strategies.Evaluates and drives the implementation of new regulatory and quality requirements for analytical control strategy in partnership with technical and manufacturing teams.Promotes continual improvement for analytical control strategies (for example digital data transformation, AI-assisted submissions preparation), quality compliance/business processes, and regulatory filing content taking into consideration internal experience and learning from the external environment.Ensures conformance to regulatory and quality requirements and internal procedures in the management of filing content and changes.Evaluates and communicates risks for CMC control strategies and quality compliance to CMC RA and PDM leadership.Develops meaningful and collaborative relationships with cross-functional teams and leaders across CMC RA and PDM.Works with CMC RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks.QUALIFICATIONSA scientific degree with directly relevant professional experience in analytical chemistry, or chemistry, with at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, or PharmD.Demonstrated track record defining analytical control strategy approaches for products taking into consideration existing and emerging ICH and regional guidance.Experience creating appropriate analytical control strategies and integrating analytical data into control strategies attributes through product lifecycle.Experience with clinical, premarket, and post-market submissions preparation, including resolution of complex regulatory questions while maintaining manufacturing and analytical flexibility.Strong strategic thinking, decision-making, prioritization skills, and communication skills (written and verbal) including experience presenting to senior leaders.Ability to influence cross-functionally to integrate regulatory and quality thinking and requirements into development plans and activities.Demonstrated organizational leadership skills at a functional level.Demonstrated commitment to creating inclusion, developing talent, and empowering teams.Gilead Core ValuesIntegrity (Doing What’s Right)Inclusion (Encouraging Diversity)Teamwork (Working Together)Excellence (Being Your Best)Accountability (Taking Personal Responsibility)The salary range for this position is: $237,660.00 - $307,560.00. 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.For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeingAs 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 or other prohibited grounds specified in applicable federal, state, and local laws.
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Locations: United States - California - Foster CityTime Type: Full timePosted on: Vor 28 TagenJob Requisition ID: R0039437At 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 of 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 fulfill their aspirations. Join Gilead and help create possible, together.Job DescriptionThe Sr Director, Analytical Regulatory Science, is responsible for supervising a team of scientists, who collaborate with product development, manufacturing, and quality teams on the construction, documentation, and defense of the analytical control strategies in regulatory submissions preparation, review, and approval. By balancing analytical knowledge and evolving regulatory expectations with manufacturing and analytical flexibility, the incumbent will support “right first time” global approvals for CMC control strategies and maintain “right to operate” throughout the product lifecycle. In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. The incumbent will report directly to the Head of CMC Regulatory Affairs – Systems and Operations at Gilead.KEY RESPONSIBILITIESDrives and supervises team members to drive analytical control strategy development and justification in regulatory filings for projects throughout product lifecycle.Guides project teams on preparation of analytical filing content and participates in authoring and reviewing of complex submissions and responses to questions from health authorities.Exercises expertise in the interpretation and implementation of ICH and regional guidelines with the goal of right first-time approval of regulatory control strategies.Evaluates and drives the implementation of new regulatory and quality requirements for analytical control strategy in partnership with technical and manufacturing teams.Promotes continual improvement for analytical control strategies (for example digital data transformation, AI-assisted submissions preparation), quality compliance/business processes, and regulatory filing content taking into consideration internal experience and learning from the external environment.Ensures conformance to regulatory and quality requirements and internal procedures in the management of filing content and changes.Evaluates and communicates risks for CMC control strategies and quality compliance to CMC RA and PDM leadership.Develops meaningful and collaborative relationships with cross-functional teams and leaders across CMC RA and PDM.Works with CMC RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks.QUALIFICATIONSA scientific degree with directly relevant professional experience in analytical chemistry, or chemistry, with at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, or PharmD.Demonstrated track record defining analytical control strategy approaches for products taking into consideration existing and emerging ICH and regional guidance.Experience creating appropriate analytical control strategies and integrating analytical data into control strategies attributes through product lifecycle.Experience with clinical, premarket, and post-market submissions preparation, including resolution of complex regulatory questions while maintaining manufacturing and analytical flexibility.Strong strategic thinking, decision-making, prioritization skills, and communication skills (written and verbal) including experience presenting to senior leaders.Ability to influence cross-functionally to integrate regulatory and quality thinking and requirements into development plans and activities.Demonstrated organizational leadership skills at a functional level.Demonstrated commitment to creating inclusion, developing talent, and empowering teams.Gilead Core ValuesIntegrity (Doing What’s Right)Inclusion (Encouraging Diversity)Teamwork (Working Together)Excellence (Being Your Best)Accountability (Taking Personal Responsibility)The salary range for this position is: $237,660.00 - $307,560.00. 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.For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeingAs 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 or other prohibited grounds specified in applicable federal, state, and local laws.
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