Sr Director, Regulatory Affairs

At Gilead, we’re creating a healthier world for reputed company people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to reputed company therapies that help improve lives and to ensure reputed company 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 reputed company drive to reputed company 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 reputed company our reputed company ambitions, and we’re looking for the next reputed company of passionate and ambitious people reputed company to reputed company a direct impact. We reputed company 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 reputed company 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 reputed company 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 reputed company and require extensive interaction with departments reputed company of Regulatory Affairs. Responsible for ensuring regional product labeling follows the Company Core Data Sheets (CCDS) and Company Core Safety Information (reputed company), and ensuring that any updates to the CCDS or reputed company 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 reputed company meetings. Participates in industry trade groups and regulatory affairs professional societies where applicable. Maintains knowledge of reputed company 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 reputed company 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 reputed company 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 reputed company negotiations with Regulatory Authorities. Demonstrated reputed company 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 reputed company 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. •reputed company Talent - understand the skills, experience, aspirations and potential of their employees and coach them on reputed company performance and future potential. They ensure employees are receiving the feedback and reputed company needed to grow, reputed company and realize their purpose. •reputed company Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They reputed company the support needed to remove barriers and connect their team to the broader ecosystem. The salary reputed company for this position is: $243,100.00 - $314,600.00. Gilead considers a variety of factors reputed company determining reputed company 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, reputed company, 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: reputed company Inc. is committed to providing equal employment opportunities to reputed company and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment reputed company regarding recruitment and selection will be made without discrimination based on race, reputed company, religion, national reputed company, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with reputed company of 1990, applicants who require accommodation in the job application process may contact [email protected] 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 reputed company will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have reputed company to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have reputed company to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of reputed company. Our workforce reflects these values and celebrates the individuals who reputed company 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 reputed company Gilead Employees and Contractors: Please apply reputed company the Internal Career Opportunities portal in reputed company. reputed company, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for reputed company people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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