Senior Manager, Regulatory Affairs

Gilead Sciences

. Develop and implement regulatory product strategies .

Posted 9/19/2026full-timeSanta Monica • California • United StatesSenior💰 $157,590 - $203,940 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory product strategies, including the preparation and submission of regulatory documents to FDA and EMA. Proven ability to lead cross-functional teams, manage regulatory projects, and ensure compliance with global regulations.

Highest-signal resume keywords

Regulatory SubmissionsFDA ComplianceProject ManagementRegulatory StrategyCross-Functional Team Leadership

ATS Keywords

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Hard Skills

Regulatory Document PreparationIND SubmissionCTA SubmissionBLA SubmissionMAA SubmissionRegulatory Risk AssessmentGlobal Regulations KnowledgeInvestigational Drug ExperienceRegulatory GuidanceHealth Authority Interaction

Soft Skills

Attention to DetailOrganizational SkillsInterpersonal SkillsVerbal CommunicationWritten Communication

Certifications & Qualifications

BA/BSMA/MS/MBAMSPhDPharmD

Industry Keywords

Regulatory AffairsClinical TrialsDrug DevelopmentRegulatory ComplianceRegulatory Intelligence

About the role

Key responsibilities & impact

Develop and implement regulatory product strategies
Represent the regulatory function on cross-functional development teams
Provide regulatory guidance and strategy, including identifying and assessing regulatory risks, mitigations, and contingencies
Plan, prepare, and review submissions to FDA, EMA, and other national authorities for clinical trials and marketing applications, including IND, CTA, BLA, and MAA submissions
Lead and oversee assigned project activities to ensure compliance with applicable FDA requirements
Manage regulatory aspects of products and projects, including timelines and deliverables
Ensure regulatory documents are accurate, complete, verifiable, and compliant with regulatory requirements
Serve as US Regulatory Lead for assigned Regulatory Project Teams
Monitor, analyze, and disseminate intelligence on regulatory matters affecting development programs
Interpret and advise on regulations, directives, and guidance
Prepare meeting requests and briefing documents, coordinate teams for health-authority meetings, and serve as primary liaison for day-to-day interactions
Coordinate and prepare responses to regulatory-authority information requests
Train, manage, and mentor regulatory affairs personnel
Engage externally in regulatory policy initiatives
Perform other duties as assigned

Requirements

What you’ll need

BA/BS with 8+ years’ relevant experience OR MA/MS/MBA with 6+ years’ relevant experience
Experience leading regulatory submissions and other regulatory projects is strongly preferred
Experience writing or updating processes
Experience working in project teams
Experience with one or more Gilead therapeutic areas and varying stages of drug development is preferred
Knowledge and understanding of global regulations and guidelines
Previous experience in the preparation and submission of regulatory documents
Previous experience attending and leading a team to prepare for major health authority interactions is highly desirable
Experience with investigational drugs, including late stage development, and marketed products desired
Ability to work in a cross-functional team environment with experience managing people and project teams
Strong attention to detail and ability to prioritize multiple tasks
Excellent organizational, computer, and documentation skills
Strong interpersonal skills, including verbal and written communication
Preferred MS, PhD, or PharmD in a scientific discipline

Benefits

Comp & perks

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical insurance
Company-sponsored dental insurance
Company-sponsored vision insurance
Company-sponsored life insurance
Flexible working policy with two days of remote working and three days working onsite