Manager, Regulatory Affairs

Gilead Sciences

Manager in Regulatory Affairs preparing regulatory submissions, providing regulatory expertise, and collaborating on projects. Join Kite, a biopharmaceutical company focused on cancer therapies in a hybrid role.

Posted 6/13/2026full-timeSanta Monica • California • 🇺🇸 United StatesSeniorLead💰 $133,195 - $172,370 per yearWebsite

About the role

Key responsibilities & impact

Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs
Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications
Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics
Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling
May be responsible for ensuring 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 and present project status updates

Requirements

What you’ll need

BS and 7+ year of experience in Regulatory Affairs or other relevant industry experience
OR MS and 5+ years of experience in Regulatory Affairs or other relevant industry experience
Degree in a scientific field is preferred
Excellent organization skills and ability to work on a number of projects with tight timelines is required
Excellent verbal and written communication skills and interpersonal skills are required
In-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories

Benefits

Comp & perks

discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off
company-sponsored medical, dental, vision, and life insurance plans

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionssafety reportslabeling changesclinical trial applicationsproduct packagingregulatory expertiseproject status updatesamendmentssupplementslicense renewals

Soft Skills

organization skillscommunication skillsinterpersonal skillsability to work on multiple projectsability to meet tight timelines

Certifications

BS in Regulatory AffairsMS in Regulatory Affairsdegree in a scientific field