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Senior Director, Regulatory Affairs CMC

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Feb 26, 2024

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Job Details

Senior Director, Regulatory Affairs CMC
United States – Remote

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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.

We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

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. Join Gilead and help create possible, together.
Job Description



Job Description

Responsibilities
Manage the tactical operations of US-based Regulatory Affairs CMC teams with responsibility for performance management and staff development.
Responsible for ensuring the development, and execution of strategy to support global development programs, new drug applications and key post-approval change control implementation plans for small molecules, biologics, and drug-device combination products in the US and Japan.
Work across all levels of business within Gilead to communicate complex CMC issues and deliver updates on major CMC regulatory guidance.
Form ad-hoc teams to address critical CMC issues on behalf of project and departmental teams.
Build partnerships, and maintain positive image of Gilead with external health authorities, trade groups, and associations.
Ensure CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries.
Lead the preparation of risk assessments on major global CMC regulatory issues.
Maintain current working knowledge of regional and global regulatory requirements, analyze current trends and anticipate changes in the regulatory requirements to adjust strategic plans as appropriate.
Initiate and contribute to local and/or global process improvements, which have a significant impact for the CMC Regulatory Affairs Department, and the Pharmaceutical Development and Manufacturing organization.
Use your industry network to maintain an awareness of CMC methodologies and disseminate this information to the business.

Knowledge, Experience and Skills
Minimum 15 years of relevant experience in Regulatory Affairs CMC, specifically extensive experience with small molecule programs is required.
Additional experience in Biologics programs and drug-device combination products is desirable. Technical experience within the (Bio-) Pharmaceutical Industry can be partially substituted for Regulatory experience.
Requires a Bachelor's degree in a relevant scientific discipline. An advanced degree is preferred.
Must have in-depth knowledge of US regulatory requirements, including ICH. Previous experience of RA-CMC requirements for Japan, and other ex-US countries is desirable.
Demonstrated success as a people manager and leader, with strong staff development skills.
A proven track record of developing global CMC strategies.
Excellent verbal and written communication and interpersonal skills.
Demonstrated ability to influence across broader functional disciplines.

The salary range for this position is: $216,070.00 - $279,620.00. 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 ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:


Please log onto your Internal Career Site to apply for this job.






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Company

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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