Manager, Regulatory Affairs

Gilead Sciences, Inc.; California (MO); Remote; USD 133,000 - 173,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a Manager for Regulatory Affairs to lead the Promotional Review Committee process. This role is crucial in ensuring that promotional materials for cancer therapies meet regulatory standards and are submitted accurately to the FDA. As a key player in a dynamic team, you will enhance operational efficiencies and support the mission of curing cancer through groundbreaking therapies. Join a forward-thinking organization that values leadership and fosters an inclusive environment, where your contributions will help shape the future of cancer treatment.

Benefits

Discretionary Annual Bonus

Stock-based Long-term Incentives

Paid Time Off

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Qualifications

• Experience in managing regulatory submissions and promotional materials.
• Strong project management skills for coordinating cross-functional teams.

Responsibilities

• Manage the PRC process and ensure compliance of promotional materials.
• Coordinate with cross-functional teams for timely FDA submissions.

Skills

Regulatory Affairs

Project Management

FDA Submission

Cross-functional Collaboration

Education

Bachelor's Degree in Life Sciences

Advanced Degree (e.g., Master's, PhD)

Tools

Promotional Review Committee (PRC) Process

FDA Form 2253

Job description

Manager, Regulatory Affairs page is loaded

Manager, Regulatory Affairs

Apply locations United States – Remote time type Full time posted on Posted 2 Days Ago job requisition id R0044860

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

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 Kite and help create more tomorrows.

Job Description

The Regulatory Affairs, Advertising and Promotion (RA Ad Promo) group seeks a Manager at Kite, a Gilead Company, in Santa Monica, CA. The Manager is responsible for managing the internal Promotional Review Committee (PRC) process and the submission of promotional materials for marketed prescription drug or biologic products to the US Food and Drug Administration (FDA). The RA Ad Promo group provides commercial regulatory strategy and leadership at Gilead and Kite to enable the business support patients and meet its commercial needs in a compliant manner.

Responsibilities

• Manage the Promotional Review Committee (PRC) process end-to-end and act as a project manager for the PRC, Marketing, and other cross-functional stakeholders in order to ensure accurate, timely, and compliant review of materials
• Schedule PRC meetings serving as the point of contact for meeting coordination
• Facilitate and document required changes and comments as part of PRC during meetings
• Manage product label updates and collaborate with cross-functional stakeholders to ensure materials are revised, resubmitted for PRC Review, and submitted to FDA on form 2253
• Ensure consistency and quality of PRC submissions
• Maintain the promotional material library to ensure active/approved materials are re-reviewed per internal guidelines
• Monitor daily operations and adherence to SOP(s)
• Create and manage timely submissions of promotional materials to the FDA (i.e. FDA 2253, Request for Advisory Comments)
• Ensure that projects are completed on schedule following established procedures and timelines as it relates to the PRC process and submissions to the FDA
• Participate in ongoing PRC Operational projects to enhance efficiencies in Kite PRC processes
• May represent group in cross-functional and Regulatory Affairs working groups and present project status updates to group
• Maintain Kite US Reference Library standards and associated Claims

The salary range for this position is: $133,195.00 - $172,370.00. Kite 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

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter.

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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 [e-mail] for assistance.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.