Business System Management Associate Director

MSD

Business System Associate Director managing complex data analytics applications in Regulatory Affairs. Leading system development and overseeing support models for the Global Labeling Operations team.

Posted 6/19/2026full-timePrague • CzechiaSeniorWebsite

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Manage and lead Business Analysts for complex data analytics application
Lead System Development, Maintenance, Enhancement and System Monitoring related initiatives
Serve as a liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business Requirements and ensuring the system is aligned to meet the business needs
Facilitate System Operations Mtgs including discussions to resolve issues and manage competing priorities utilizing proper escalation pathways to ensure limited impact to delivery timelines for workstream activities
Lead the development of User facing System Resources ensuring supporting materials remain aligned with the current system version.
Work collaboratively with stakeholders in Global Labeling, System Support Team, IT and Learning & Development organizations to meet required delivery timelines associated with User Resources
Lead System Releases in collaboration with IT Business Partners including activities relating to Requirements Gathering, Documentation, Testing, Implementation, Deployment and Hypercare phases
Facilitate and oversee the System Support Model for systems within remit including: Monitor user support cases, ensuring thorough root cause investigations are conducted, CAPAs are detailed and closed effectively and communication is consistently done to reduce instances of recurrence.
Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users
Conduct System Administrator activities supporting the alignment of the Global organizational processes with the System Capability cross-functionally and cross-regionally
Facilitate System Specific Global User Group Forums, Release/System Communication authoring and Program Updates, as requested

Requirements

What you’ll need

BS/BA in science, engineering, IT or related discipline with functional working experience in System Development/Management within GxP regulated areas preferred
Requires 10+ years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and Digital Enablement experience strongly preferred, and applied knowledge of SDLC and IT System/Business System Management
Candidate must be proficient with IT system and business process support, preferably in the Regulatory or Labeling Management space with general understanding of Label Update process
Must have experience with audit/inspection facing support for GxP systems and ability to communicate complex concepts in high pressure situations
Analytical and process minded with a short learning curve for systems and processes to drive results based on specified objectives
Demonstrates strong leadership and problem-solving skills and ability to gather relevant facts and distill information
Effortlessly works in a collaborative manner with cross-functional and cross-regional users and stakeholders while building strong working relationships
Effective communication skills (verbal and written)
Ability to work cooperatively with others and provide significant contributions as a member of a team in addition to serving in a leadership capacity
Strong organizational skills
Demonstrates strong attention to detail
Process-oriented and proficient with GxP (GMP) requirements with experience working in a highly regulated industry
Experience with business process mapping and system design for workflow management is an asset
Strong aptitude for authoring Technical Guidance documentation such as User Guidance and Standard Operating Procedures (SOP) and change control management is required
Good understanding of SDLC Documentation requirements and processes pertaining to system management for GxP/GMP applications

Benefits

Comp & perks

Exciting work in a great team, global projects, international environment
Opportunity to learn and grow professionally within the company globally
Hybrid working model, flexible role pattern
Pension and health (Canadian Medical) contributions
Internal reward system plus referral program
5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution
Cafeteria for tax free benefits according to your choice (meal vouchers, sport, culture, health, travel, etc.)
Multisport card, Vodafone, Raiffeisen Bank and Foodora discount programs
Up-to-date laptop and iPhone, parking in the garage, showers, refreshments
Competitive salary, incentive pay, and many more

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

System DevelopmentSystem ManagementSDLCGxPGMPBusiness Process MappingWorkflow ManagementTechnical Guidance DocumentationUser GuidanceStandard Operating Procedures

Soft Skills

LeadershipProblem-solvingAnalyticalCollaborationCommunicationOrganizationalAttention to DetailProcess-orientedRelationship BuildingAdaptability