Director, Regulatory Affairs CMC

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

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses

worldwide.

Responsibilities

• Responsible for leading all CMC regulatory activities for assigned project(s), in line with ICH requirements, regional requirements, scientific knowledge, and company policies and procedures.
• Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages.
• Actively collaborates with internal teams (including Technical Development, Manufacturing, Supply Chain and Quality) to identify and rank risks, propose risk mitigation plans, and execute robust CMC regulatory strategies.
• Leads CMC regulatory project teams and serves as core member of cross-functional PDM strategy teams.
• Ensures up-to-date knowledge of highly complex regulatory requirements, contributes to preparation of new regulatory guidances, comments on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management.
• Provides advice and drives decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs, and affiliates on internal meetings and leads global Health Authority interactions for CMC related topics.
• Initiates or contributes to local and/or global process improvements which have a significant impact on the business.
• Provides regulatory impact assessments for changes managed in the quality systems and participates in technical risk assessment exercises.
• Coaches and mentors junior regulatory CMC RA staff.
• Contributes to update, maintain, and verify documents, submissions and registrational details in a validated Regulatory Information Management system.
  
  

Qualifications

• Bachelor's degree and 12 years of experience in CMC Regulatory Affairs (CMC RA) or other relevant industry experience or 10 years of experience with a master's degree/advanced degree.
• Requires a bachelor’s degree in a relevant scientific discipline. An advanced degree is preferred.
• A proven track record of developing and leading global CMC regulatory submissions strategies and submissions in all phases of drug development, including life cycle management (IND, IMPD/CTA, NDA, MAA, etc.).
• Deep understanding of global regulatory requirements and guidelines.
• Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment.
• Collaborative, proactive, and highly organized approach to work.
• Excellent verbal and written communication, negotiation and interpersonal skills.
  
  

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the
  
  

way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current
  
  

performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and

realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding
  
  

them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The Salary Range For This Position Is:

Bay Area: $210,375.00 - $272,250.00.

Other US Locations: $191,250.00 - $247,500.00.

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:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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.

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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 apply via the Internal Career Opportunities portal in Workday.