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 leading complex global submissions and fostering cross-functional collaboration. Possesses advanced knowledge of regulatory requirements and submission best practices, ensuring compliance and effective communication across teams.

Highest-signal resume keywords

Regulatory Submission ManagementProject ManagementLeadership Without AuthorityKnowledge of Regulatory RequirementsExperience in Biopharma Industry

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Submission ManagementRegulatory Project ManagementFull-Cycle Submission ManagementRegulatory Requirements KnowledgeResource ManagementReporting and Tracking ToolsAgile MethodologiesSubmission PlanningAttention to DetailTeam Dynamics Understanding

Soft Skills

Interpersonal SkillsCommunication SkillsTeam CollaborationProblem-SolvingCoaching and Mentoring

Tools & Technologies

VeevaDocubridgeSmartsheetPlaniswareMicrosoft Project

Certifications & Qualifications

PMPProject Management Certification

Industry Keywords

BiopharmaNDAMAABLASNDAINDRtQICH RequirementsHealth Authority RequirementsTherapeutic Areas

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, anticipate obstacles, and develop solutions
Foster communication among Regulatory Affairs groups and cross-functional partners
Provide Regulatory Submission Management support for programs, projects, and initiatives
Manage 2–4 major regulatory submissions, including NDAs, MAAs, BLAs, sNDAs/T2Vs, INDs, and RtQs
Support portfolio planning, lead RSM sub-capabilities, or lead submission execution for specific regions
Coordinate, track, and prepare project information, minutes, timelines, action items, and functional deliverables
Lead local and global process improvements across therapeutic areas
Organize and lead preparation of documents for internal committees and external stakeholders
Act as a subject matter expert for projects, processes, and regions
Ensure work complies with company policies, established practices, technical specifications, ICH requirements, and health authority 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 of experience with BS/BA, or 8+ years with MS/MA or MBA
Relevant submission management, regulatory project management, or regulatory operations experience in the biopharma industry
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 full-cycle submission management and submission management best practices and tools
Advanced knowledge of functional regional or therapeutic-area submission planning, 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
PharmD/PhD with 5+ years of relevant experience is preferred
PMP or other project management certification is a plus
Knowledge of Agile Methodologies is a plus
Veeva, Docubridge, Smartsheet, Planisware, or Microsoft Project experience 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
Potential travel opportunities
Coaching, training, and guidance for less experienced colleagues