Sr Reg Affairs Assoc

We’re here for one reason – 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. Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.

Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our El Segundo/Thousand Oaks office beginning in January 2027. While this role will be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite. This role may also be located at our Foster City location with the same flexible working policy.

Responsibilities

• Prepare regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements, and scientific and company policies and procedures.
• Handle submissions including safety reports, amendments, supplements, license renewals to clinical trial applications (e.g., IND, CTAs), and marketing authorizations, as well as original marketing authorization applications for territories other than the US and EU, and contribute to preparation of US and EU marketing authorizations.
• Provide regulatory expertise to labeling changes and to submission teams on specified projects and topics.
• Provide input to senior Regulatory Affairs professionals in the preparation of country-specific labeling.
• Ensure product packaging and associated information is updated and maintained in accordance with the product licenses.
• Participate in group meetings and local and global product submission team meetings; present project status updates and strategy approaches to moderately complex programs/projects.
• Responsible, under the guidance of an immediate manager, for self-development and acquisition of required regulatory skills and knowledge.
• Initiate or contribute to local process improvements impacting the Regulatory Affairs function or other departments.
• Demonstrate excellent organization skills and ability to work on multiple projects with tight timelines.
• Utilize excellent verbal and written communication skills and interpersonal skills.
• Apply in-depth knowledge of regulatory requirements, including ICH and regional requirements for assigned territories; act as a knowledgeable resource within the department on a range of topics.

Requirements

• BS and 5+ years of experience in Regulatory Affairs or other relevant industry experience OR MS and 3+ years of experience in Regulatory Affairs or other relevant industry experience.
• Degree in a scientific field is preferred.

People Leader Accountabilities

• Create Inclusion: Know the business value of diverse teams, model inclusion, and embed the value of diversity in team management.
• Develop Talent: Understand the skills, experience, aspirations, and potential of employees; coach them on current performance and future potential, ensuring they receive the feedback and insight needed to grow.
• Empower Teams: Connect the team to the organization by aligning goals, purpose, and organizational objectives; hold them accountable and provide support to remove barriers.

Pay

The salary range for this position is:

• Other US Locations: $115,260.00 - $149,160.00
• Bay Area: $126,820.00 - $164,120.00

Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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

• Company-sponsored medical, dental, vision, and life insurance plans.
• Eligible employees may participate in additional benefit plans, subject to the terms and conditions of the applicable plans.

For additional benefits information, visit: Gilead Careers - Compensation, Benefits, and Wellbeing.