Sr Director, Regulatory Affairs

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.

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).
• 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.

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.

Salary Range

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.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans*

Equal Employment Opportunity

Gilead Sciences 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.