Associate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory Affairs
Foster City, CA, United States
Associate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory Affairs 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 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
The Associate Director, Analytical Regulatory Science, collaborates with product
development, manufacturing and quality teams on the construction, documentation and defense of the analytical control strategies in regulatory submissions preparation and review.
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 incumbent will be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
Prepares analytical filing content of complex submissions and related supporting activities. Prepares responses to questions from health authorities.
Interprets and implements ICH and regional guidelines with the goal of right first time approval of regulatory control strategies.
Evaluates and implements new regulatory and quality requirements for analytical control strategy in partnership with technical and manufacturing teams.
Evaluates and implements continual improvement for analytical control strategies, 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 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.
Demonstrates success in influencing without positional authority within a highly matrixed organization.
Demonstrates and models Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities.
May participate in business process development initiatives or represent the company in industry consortia.
Requirements:
Bachelors and 10+ years of experience OR
Masters and 8+ years of experience OR
PhD and 2+ years of experience
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 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
The Associate Director, Analytical Regulatory Science, collaborates with product
development, manufacturing and quality teams on the construction, documentation and defense of the analytical control strategies in regulatory submissions preparation and review.
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 incumbent will be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
Knowledge & Details:
Prepares analytical filing content of complex submissions and related supporting activities. Prepares responses to questions from health authorities.
Interprets and implements ICH and regional guidelines with the goal of right first time approval of regulatory control strategies.
Evaluates and implements new regulatory and quality requirements for analytical control strategy in partnership with technical and manufacturing teams.
Evaluates and implements continual improvement for analytical control strategies, 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 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.
Demonstrates success in influencing without positional authority within a highly matrixed organization.
Demonstrates and models Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities.
May participate in business process development initiatives or represent the company in industry consortia.
Requirements:
Bachelors and 10+ years of experience OR
Masters and 8+ years of experience OR
PhD and 2+ years of experience
The salary range for this position is: $177,905.00 - $230,230.00. 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-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States: 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 or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.
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Job Requisition ID R0041226
Full Time/Part Time Full-Time
Job Level Associate Director
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