Sr Director, Regulatory Affairs (United States - California - Foster City)

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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

 

Located in Foster City, CA - this is a hybrid (3 days onsite) role.

As a Sr Director, Regulatory Affairs at Gilead, you will...

• Responsible for leading and providing strategic input to all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Responsible for leading a team of Regulatory professionals supporting both early phase and marketed products.
• Responsible for ensuring responsibilities of Applicant and/or Marketing Authorization Holder defined in legislation or regulatory guidance's are met for assigned product(s) and territories.
• Responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories.
• Prepare and/or manage others' submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
• Responsible for ensuring regional product labeling follows the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI), and ensuring that any updates to the CCDS or CCSI are implemented in a timely manner.
• Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the marketing authorization.
• May act as regulatory project team representative for specified products.
• Represents Regulatory function at internal and external meetings.
• Participates in industry trade groups and regulatory affairs professional societies where applicable. Maintains knowledge of complex regulatory requirements, contributes to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management.
• Deputizes effectively and reliably for Executive Director International Regulatory Affairs within the Company and with Regulatory Authorities.
• Initiates or contributes to local and / or global process improvements which have a significant impact on the business.

Core Competencies:

• Excellent verbal and written communication skills and demonstration of excellent interpersonal skills are required.
• Excellent influencing and negotiation skills.
• Excellent leadership and people management skills, in terms of management of workload, training and development of direct reports are required.
• Schedules and arranges own activities and those of direct report(s).
• Excellent organizational skills and ability to ensure a multitude of tasks are appropriately delegated, managed and completed.
• Extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an understanding of current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business.
• Proven track record of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
• Demonstrated success in leading one or more teams in preparation of submissions and maintenance of marketing authorizations.
• Work is performed under consultative direction towards corporate regulatory goals and objectives.
• Is recognized as an expert resource for Regulatory Advice in other departments.

Basic Qualifications:

• Bachelor's degree in a relevant discipline (an advanced degree is highly desirable), with 14+ years of regulatory affairs experience or master's degree in the related areas with 12+ years of regulatory affairs experience.

• Inflammation experience is highly desirable.

• Previous people management experience and direct experience working with Regulatory Authorities in assigned territories is required.

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: $243,100.00 - $314,600.00. 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:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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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 View email address on apply.placed-app.com for assistance. ]]> <