Associate Director, Business System Labeling Management – Regulatory Affairs

MSD

. Manage and lead Business Analysts for complex data analytics applications .

Posted 11/12/2026full-timeUnited StatesSenior💰 $129,000 - $203,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in managing GxP business systems, including system lifecycle management, release management, and operational support. Proficient in facilitating cross-functional collaboration and communication while ensuring compliance with regulatory standards.

Highest-signal resume keywords

10+ Years Experience In Pharmaceutical Regulatory Affairs OperationsEnd-To-End Ownership Of GxP Business SystemsProficiency With GxP/GMP RequirementsStrong Analytical And Problem-Solving SkillsExperience With Audit/Inspection-Facing Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

System Lifecycle ManagementRelease ManagementChange Control ManagementBusiness Process MappingWorkflow Management System DesignSDLC KnowledgeLabel Update Process UnderstandingTechnical Guidance DocumentationUser Guidance AuthoringSOP Development

Soft Skills

LeadershipCommunicationOrganizational SkillsAttention To DetailCollaborative Problem-Solving

Industry Keywords

GxPGMPRegulatory AffairsLabeling ManagementCompliance Risk ReductionSystem Support ModelsGlobal LabelingCross-Functional CollaborationHigh-Pressure CommunicationSystem Administrator Activities

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Manage and lead Business Analysts for complex data analytics applications
Lead system development, maintenance, enhancement, and system monitoring initiatives
Liaise between Global Labeling business users and IT partners to define business requirements and align systems with business needs
Facilitate system operations meetings, resolve issues, and manage competing priorities through escalation pathways
Lead development and maintenance of user-facing system resources
Collaborate with Global Labeling, System Support, IT, and Learning & Development stakeholders
Lead system releases through requirements gathering, documentation, testing, implementation, deployment, and hypercare
Oversee system support models, including monitoring support cases, root-cause investigations, CAPAs, and recurrence-reduction communications
Identify support-model improvements to reduce compliance risk and increase efficiency
Conduct system administrator activities aligning global processes with system capabilities across functions and regions
Facilitate global user group forums, author release and system communications, and provide program updates

Requirements

What you’ll need

10+ years of experience in Pharmaceutical Regulatory Affairs Operations
Demonstrated end-to-end ownership and management of GxP business systems, including system lifecycle, release management, change control, and operational support
Applied knowledge of SDLC
Labeling Process and Systems Digital Enablement experience strongly preferred
BS/BA in science, engineering, IT, or related discipline preferred
Proficiency with IT system and business process support, preferably in Regulatory or Labeling Management
General understanding of the Label Update process
Experience with audit/inspection-facing support for GxP systems
Ability to communicate complex concepts in high-pressure situations
Strong analytical, process-minded, leadership, problem-solving, organizational, communication, and attention-to-detail skills
Ability to work collaboratively with cross-functional and cross-regional stakeholders
Ability to handle multiple tasks under pressure across global time zones
Proficiency with GxP/GMP requirements in a highly regulated industry
Strong aptitude for authoring technical guidance documentation, user guidance, SOPs, and change control management
Good understanding of SDLC documentation requirements and processes for GxP/GMP applications
Experience with business process mapping and workflow management system design is an asset

Benefits

Comp & perks

Annual bonus
Long-term incentive, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
Hybrid work arrangement