Compliance

• Own Custody & Compliance end-to-end, including strategy, roadmap, priorities, budget, and business results.
• Define and track key metrics for deposits, withdrawals, KYC, fraud, and customer activation.
• Improve customer onboarding and money movement speed and conversion.
• Balance risk prevention with customer experience and commercial impact.
• Build financial and operational models and make data-driven business decisions.
• Work directly with C-level stakeholders on strategy and priorities.
• Own custody infrastructure and relationships with custody providers.
• Own deposit and withdrawal flows across the GoMining ecosystem.
• Improve transaction processing speed, reliability, and success rates.
• Manage incidents and critical issues related to customer funds.
• Own operational implementation of KYC, AML, and Travel Rule requirements.
• Build scalable compliance operations, including case management, decision SLAs, escalation processes, and operational workflows.
• Analyze false positives and missed fraud cases.
• Develop fraud prevention guardrails and data-driven suspicious-activity detection.
• Own relationships with custody, KYC, AML, and infrastructure providers; negotiate terms and drive integrations.
• Lead a dedicated engineering team and work directly with the Tech Lead.
• Own priorities, backlog, releases, delivery, team goals, hiring, development, and performance decisions.
• Use AI and automation to keep the team lean and increase execution speed.

General Manager – Custody & Compliance

• Manage and monitor expedited and non-expedited Individual Case Safety Report (ICSR) submissions and exchanges
• Ensure compliance with global pharmacovigilance reporting requirements and internal procedures
• Conduct monthly ICSR reconciliation activities with clients and safety partners
• Support gateway-to-gateway testing for health authority submissions and safety partner exchanges
• Assist with investigation, documentation, and resolution of submission-related deviations and CAPAs
• Generate Argus-based line listings and summary tabulations for periodic safety reports
• Assist in creating, validating, and quality reviewing custom reports and reporting outputs
• Support setup, verification, and maintenance of periodic reporting requirements across global markets
• Coordinate periodic report submissions in compliance with local regulatory requirements
• Support pharmacovigilance reporting services and operational excellence
• Research, collect, and maintain global pharmacovigilance reporting requirements
• Conduct monthly regulatory surveillance and impact assessments
• Support regulatory intelligence tools, mailboxes, tickets, queries, and ad hoc projects
• Provide guidance on evolving pharmacovigilance regulations and reporting obligations
• Perform Performance Qualification (PQ) testing for Argus upgrades, patches, and custom developments
• Support implementation and validation of territory-specific and custom E2B profiles
• Participate in data migration testing and submissions-related system enhancements
• Contribute to projects improving efficiency, quality, and system performance
• Prepare and maintain xEVMPD submissions, updates, removals, and new product entries
• Conduct peer review and quality control of xEVMPD submissions
• Support bulk updates, QPPV changes, master file location updates, and developmental product registrations

Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
• Provide strategic regulatory input as required
• Develop and/or review submission documents to ensure compliance with regulatory standards
• Represent Global Regulatory Affairs at project team meetings with external and internal customers
• Work within project teams and lead regional or global projects when necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, project trackers, and regulatory intelligence tools; update Regulatory Leadership
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Provide input into regulatory strategy and timeline development for new study opportunities
• Assist in establishing company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients
• Represent Global Regulatory Affairs at business development meetings

Regulatory Manager – Senior Regulatory Manager

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Ensure timely preparation of organized, quality regulatory submissions in compliance with applicable regulations
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
• Develop and review documents for Regulatory Authorities and Ethics Committees
• Represent Global Regulatory Affairs at project team and business development meetings with internal and external customers
• Work within project teams and lead regional or global projects when necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, trackers, and regulatory intelligence tools; update Regulatory Leadership
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Provide input into regulatory strategy and timeline development for new study opportunities
• Assist in establishing company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients

• Own information security risk management, control assurance, and ISO 27001 ISMS governance across a regulated group spanning banking, consumer finance, and technology
• Form an independent view of security risk and challenge whether proposed controls address it, working directly with the Group CISO
• Assess control design and operating effectiveness across IAM, cloud, endpoint security, monitoring, vulnerability management, data protection, and secure development
• Turn risk and control data into clear, decision-ready reporting for governance forums
• Own the security risk process end to end, including assessment, treatment, acceptance, monitoring, and reporting
• Maintain the risk register and challenge risk assessments and treatment plans
• Maintain the security control framework and test controls using evidence, data, sampling, or technical validation
• Drive remediation with control owners
• Maintain the ISO 27001 ISMS, including policies and standards, Statement of Applicability, risk records, control evidence, exceptions, and key security registers
• Track control deficiencies, findings, exceptions, and remediation actions
• Define KRIs and control metrics and flag where management decisions or escalation are needed

GRC Lead

• Support the execution of global regulatory CMC strategies for marketed and development products
• Contribute to the preparation and submission of regulatory CMC documentation for small molecules
• Review CMC sections of regulatory submissions, interactions, and responses with regulatory agencies
• Contribute to global regulatory CMC strategies for commercial products
• Work with regulatory colleagues to develop global regulatory CMC strategies and submissions
• Provide regulatory CMC guidance to cross-functional teams and key stakeholders
• Support regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations

Compliance jobs in Serbia

General Manager – Custody & Compliance

Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

Regulatory Manager – Senior Regulatory Manager

Regulatory Manager – Senior Regulatory Manager

GRC Lead

Senior Regulatory CMC Consultant - Small Molecule, Veeva RIM