Predrag Denkovski Email & Phone Number

Bothell, WA, US

New York, New York, US

Bothell, Washington, US

• Recruited to lead and build the Regulatory Operations area of the company, which includes the Regulatory Submission Management, Information Management and Project Management, including Advertising & Promotions briefly..
• Evaluated the current state, developed a strategic plan and tactical roadmap, obtained cross-functional and upper management approval to proceed, and implemented the strategy for the new department
• Implemented the GRT Operating Model within Regulatory, and Submission Processes Champions cross-functional team within R&D to drive submission operational processes and improvements
• Implemented Lorenz DocuBridge and a Regulatory Submission Request site for submission management
• Developed the strategy, managed leadership business case approval, and now driving and steering the implementation of Veeva RIM Vaults and the Veeva platform with the organization

North Chicago, Illinois, US

• Built and managed a global Regulatory Affairs operations function within Abbvie with regard to people, processes and technologies, and expanded the function to include project management, submission management (content.
• Evaluated the current state, developed a strategic plan and tactical roadmap, obtained cross-functional and upper management approval to proceed, and implemented the strategy for the new RSP department
• Successfully recruited the team, and developed the departmental charter, processes, standards and resource model for the new Regulatory Strategic Planning, Submission Management, Submission Publishing Operations and.
• Implemented a new Global Regulatory Product Team project plan template for Global Regulatory Affairs, and successfully transitioned the plans into a centralized MS Project Server environment
• Configured reports using analytics tools (QlikView and Swimlane) for enterprise use via SharePoint
• Drove the integration of the GRPT project plans with clinical, operational and commercial plans to further improve transparency, efficiency and effectiveness

Plano, Texas, US

• Recruited to lead and build the Regulatory Operations area of the company. Managed 2 consultants and all aspects of the department’s operations, including gap analysis, strategies, objectives, planning, scheduling.
• Oversaw strategy and 100% compliance/quality for documents and submissions provided to the FDA
• Co-led the NDA/MAA Submissions teams (cross-functional and with partners), including driving charting, project planning, document delivery, process development and technology implementation activities
• Led the enterprise move to eDMS for controlled documents, by leading the acquisition of NextDocs and implement it for Regulatory, Submission, SOP, Training, Computer System Validation and Contracts
• Led implementation of outsourcing eCTDs, and SDTM, utilizing Octagon
• Acquired system ownership for enterprise information (portal, search, content, collaboration, process), document and submission management technologies, which included responsibilities for SOP management, system change.

Dublin 2, IE

• Increased department’s responsibilities to include Regulatory Operations, Medical Writing, and Library & Intelligence services, and leadership of the BioNeurology Technology Steering Group (BTSG). Created and developed.
• Oversaw strategy and 100% compliance/quality for documents and submissions provided to regulatory agencies in support of FDA CBER & CDER NDAs/INDs/DDMACs, EMA CP MAA, EU NA IMPDs/CTAs, and Health Canada CTAs.
• Led the BTSG in driving process and technlogy changes throughout the global organization.
• Drove enterprise efficiency and effectiveness by migrating paper submission to fully electronic submissions for all its products and in all markets.
• Led implementation of EMC Documnetum, EMC Documnetum & Microsoft SharePoint Document Review Center integration, Microsoft SharePoint/InfoPath/FAST Enterprise Search, ISI eCTD Xpress/Publisher and PlanView enterprise.
• Led the Business Continued Program within the Development organization, including team chartering, plan development, technology implementation and change management.

Toronto, Ontario, CA

• Established the first global Regulatory Operations department in the enterprise, and then evolved it into a centralized R&D Informatics function with a team of up to 15 high performing employees. Managed all aspects of.
• Oversaw strategy and 100% compliance/quality for documents and submissions provided to regulatory agencies in support of Health Canada ANDSs/CTAs, FDA CDER ANDAs, and EU NA (MHRA and MEB-CBG mainly) MRP and DCP MAAs.
• Drove efficiency and effectiveness with move to full e-submissions for all its products by implementing the Electronic Regulatory Submission project, which moved the global enterprise into the eCTD environment by.
• During tenure, >50% of all generic eCTD submissions to Health Canada and FDA were from Apotex.
• Led implementation of Lorenz LabelBridge/Validator, Microsoft Project Server/Access/SharePoint, and Sparta Systems TrackWise and major upgrades of Lorenz DocuBridge and BroadVision 1-To-1 Content.
• Led the Reg & Medical Affairs Management Forum and Joint Scientific Projects Steering Committee in driving process and technlogy changes throughout the global organization.

Worked the summer months during school.

Msc, Pharmacology

Bsc, Physiology & Pharmacology