Senior Regulatory Affairs Associate, CMC

Gilead Sciences

Senior Regulatory Affairs Associate managing regulatory submissions for investigational and commercial cancer therapies. Supporting global programs while adapting to a fast-paced environment.

Posted 6/17/2026full-timeSanta Monica • California • 🇺🇸 United StatesSenior💰 $115,260 - $149,160 per yearWebsite

About the role

Key responsibilities & impact

Responsible for preparing moderately complex regulatory submissions requiring interactions with departments outside of Regulatory Affairs CMC for investigational and commercial products
Supports operational and life cycle management of regulatory CMC submissions in support of global commercial and clinical programs
Identify CMC risk areas and suggest alternative scenarios and course of action
Act as Regulatory CMC representative on cross-functional project teams
Ensure that CMC-specific registered technical details are updated and maintained
Manage Regulatory CMC commitments made to Health Authorities
Support Annual Product Review or Vector Product Review for all products
Present project status updates and strategic approaches to moderately complex programs

Requirements

What you’ll need

BA/BS degree with 5 years of relevant experience in Regulatory Affairs CMC and/or biopharmaceutical industry or 3 years of relevant experience with a master's degree
Some knowledge of ICH requirements
understanding of current global trends in CMC Regulatory Affairs
Organizational skills – detail oriented and able to adapt to frequent changes in product activity
Excellent interpersonal, verbal and written communication skills
High energy level and a positive outlook coupled with the requisite “can do” attitude
Self-motivated with a strong sense of ownership
High degree of professionalism, ethics and integrity
Comfortable in a fast-paced company environment with minimal direction

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsCMC risk assessmentlife cycle managementproject managementtechnical detail managementAnnual Product ReviewVector Product ReviewICH requirementsglobal trends in CMC Regulatory Affairsbiopharmaceutical industry experience

Soft Skills

organizational skillsdetail orientedadaptabilityinterpersonal skillsverbal communicationwritten communicationself-motivatedownershipprofessionalismpositive attitude

Certifications

BA/BS degreemaster's degree