Associate Director, Regulatory Submission Management

Gilead Sciences

. Direct planning and execution of regulatory programs and submission activities for highly complex global submissions and initiatives .

Posted 9/17/2026full-timeFoster City • California • United StatesSenior💰 $182,070 - $235,620 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in regulatory submission management and project management within the biopharma industry, with a strong focus on compliance with global health authority requirements and ICH guidelines. Proven ability to lead cross-functional teams, manage multiple submissions, and implement process improvements effectively.

Highest-signal resume keywords

Regulatory Submission ManagementProject ManagementBiopharma Industry KnowledgeLeadership and Team DevelopmentNegotiation and Conflict Resolution

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Submission Management Best PracticesRegulatory Requirements KnowledgeFull Cycle Submission ManagementGlobal Health Authority ComplianceSubmission Planning and ExecutionRegulatory Portfolio PlanningTechnical Health Authority AdvisoryResource ManagementContinuous Improvement InitiativesReporting and Tracking Tools

Soft Skills

Interpersonal SkillsTeam Dynamics UnderstandingAttention to DetailCommunication SkillsConflict Resolution

Tools & Technologies

VeevaDocubridgeSmartsheetPlaniswareMicrosoft Project

Certifications & Qualifications

PMP Certification

Industry Keywords

Regulatory AffairsNDAMAABLASNDAINDRtQICH RequirementsAgile MethodologiesBiologics Development

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Direct planning and execution of regulatory programs and submission activities for highly complex global submissions and initiatives
Partner with RA Liaisons and GRAD to generate global filing plans and maintain program-level regulatory milestone timelines
Lead regulatory portfolio planning for programs or submissions as needed
Direct project and initiative communications and keep stakeholders informed of project activities and status
Plan and conduct regulatory submission team meetings and develop solutions to anticipated obstacles
Foster communication among Regulatory Affairs groups and cross-functional partners
Provide Regulatory Submission Management support for programs, projects, and initiatives
Organize ad hoc working groups and attend sub-team meetings
Develop and implement continuous improvement, innovation, and optimization initiatives
Manage 2–4 major regulatory submissions, including NDAs, MAAs, BLAs, sNDAs/T2Vs, INDs, and RtQs
Support portfolio planning, lead an RSM sub-capability, or lead submission execution for a specific region
Coordinate, track, and prepare project information, minutes, timelines, action items, and functional deliverables
Ensure integration of project timing, scope, and resources
Initiate or contribute to local and global process improvements across therapeutic areas
Organize or lead preparation of documents for internal committees and external stakeholders
Act as a subject area expert for projects, processes, and regions
Ensure work complies with company practices, policies, processes, technical specifications, and health authority requirements
Ensure submissions align with ICH requirements and applicable local or regional regulatory requirements
Oversee external contractors when applicable
Coach, train, and guide less experienced Submission Management colleagues
Create inclusion, develop talent, and empower teams as a people leader

Requirements

What you’ll need

10+ years with BS/BA, or 8+ years with MS/MA or MBA
10+ years of relevant submission management, regulatory project management or regulatory operations experience in the biopharma industry with BA/BS; or 8+ years with MA/MS/MBA; or 5+ years with PharmD/PhD
Proven effectiveness managing submission teams in life sciences
Proven track record of successfully managing multiple submissions simultaneously
Knowledge of drugs and biologics development and regulatory requirements
Knowledge of regulatory submission requirements specific to key regions such as the US and EU
Knowledge of global health authority requirements and global and regional trends
Strong negotiation and conflict resolution skills
Complete knowledge of full cycle submission management
Advanced knowledge of submission management best practices and tools
Significant biopharma industry, drug development, and technical knowledge
Ability to advise cross-functional partners on technical health authority requirements and RSM processes
Advanced knowledge of regional or therapeutic-area submission plans, deliverables, and resource management
Strong leadership presence and ability to lead without authority and influence programs, projects, and initiatives
Ability to understand and communicate technical, scientific, and business elements clearly and concisely
Strong interpersonal skills and understanding of team dynamics
Ability to work successfully in a team-oriented, highly matrixed environment
Quality-driven with strong attention to detail and accuracy
Advanced knowledge and skill with reporting and tracking tools
Ability to travel when needed
PMP or other project management certification is a plus
Knowledge of Agile methodologies is a plus
Veeva, Docubridge, Smartsheet, Planisware, and Microsoft Project knowledge is a plus

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
Employee benefits package
Reasonable accommodation in the job application process