Roxana Handragel

Regulatory Project lead for regulatory outsourcing services - client dedicated - End to End Regulatory Lifecycle maintenance processes, including Artworks.

• Overseeing comprehensive project planning, coordinating deliverables and management of execution to ensure alignment with strategic goals and procedures.
• Ensure adherence to project timelines, maintaining high-quality standards and managing global budget effectively.
• Supporting contract drafting and revisions, managing creation and update of internal project procedures.
• Overseeing invoicing process and providing financial forecasting and revenue information along with performance metrics / KPIs overview for defined service level agreements with clients.
• Identify opportunities to expand existing contracts and services and address evolving client needs by proposing new project scopes or improvements.
• Overseeing team of more than 80 resources (Global and Local Regulatory Affairs & Artworks) by delegating tasks, offering guidance, fostering team communication and integration, mentoring as needed and supporting individual career development while promoting healthy work-life balance.
• Proactively identifying and resolving project-related issues, monitoring key performance indicators and contributing to overall governance framework, while continuously looking at improving ways of working.
• Demonstrating strong understanding of regulatory requirements and of client procedures and processes to effectively support delivery team in fulfilling their responsibilities
• Committed to delivering high-quality, timely services that meet or exceed client expectations and contribute to consistently strong client satisfaction survey scores.
• Monitor regulatory changes affecting operation processes and providing clients with timely regulatory intelligence and actionable proposals for integrating new regulatory requirements into procedures by developing improved or new ways of working.

Regulatory Project lead for regulatory outsourcing services - client dedicated - End to End Regulatory Lifecycle maintenance processes, including Artworks.

• Maintaining overall responsibility for project planning, deliverable coordination and management.
• Ensuring project timelines are met, quality is maintained and that global budget is managed.
• Supporting contract drafting and updates, handling invoicing process, providing financial forecasts and overviews on managed projects.
• Identifying new project opportunities or addressing client needs by expanding scope of current contracts.
• Assigning tasks and providing support and advice for PXL team to manage project related requests, ensuring their adhesion to team, mentor them in case of need and help them with their personal career development, establishing life-work balance.
• Responsible for proactively identifying and addressing project issues, for tracking key metrics and integral part of project governance structure.
• Good understanding of client's procedures and process to support delivery team to complete their tasks.
• Main aim is to provide clients with high quality services, accurate and on time to achieve good client satisfactory survey scores, as done within past years.
• Support client with transformation processes and change management related activities
• Oversaw daily operations to achieve high productivity levels.
• Delivered exceptional customer service by proactively listening to concerns and answering questions.
• Applied critical thinking to analyze problems, evaluate solutions and select best decisions.

Product Manager for a product portfolio enclosing both Medicinal Products and Medical Devices - client dedicated - End to End Regulatory Lifecycle maintenance processes.

• Keeping oversight of changes across both types of products in all countries where product is approved (46 eCTD dossiers and 1 CE marked medical device Technical File).
• Attend meetings and provide status reports for products both with client and internally with Project Lead.
• Performing Regulatory Impact Assessments for changes including estimation of costs, classification of changes and strategies for submissions.
• Responsible for first time quality and on time submission of changes to competent authorities.
• Ensuring follow-up on changes to obtain approvals and implementation of these changes internally with client.
• Create and maintain accurate and up-to-date information/documentation within applicable client tools and systems.
• Raise deviation within client and Parexel TrackWise systems where procedures and/or timelines have not been followed, including investigation records and CAPAs.
• Coordinate with delivery team and Subject Matter Experts to assign tasks and prepare documentation and strategy for submissions.
• Development and maintenance of client dedicated procedures for regulatory lifecycle maintenance activities (medicines and devices).

• Being part of this consultancy company offered more perspective on pharmaceutical industry approach in terms of working for clients based on contract specific details. It provided chance to learn and have better understanding at European and WW level of regulatory activities undertaken by different companies acting in this field.
• Developed experience by being involved in providing support for clients in different EU countries in remit of Local Regulatory Affairs while working for European procedures Centralized Procedure/Mutual Recognition Procedure/Decentralized Procedure but also on National Procedures and getting good knowledge and understanding of local requirements in countries such as Cyprus, Portugal, Malta, Greece and Spain.
• Experience in coordination of submissions of variations/renewals in Europe and WW (except US) keeping close communication with client and local affiliates/partners in all countries involved.
• Proficient with different electronic systems/software's and databases for Regulatory. Familiar with EDMS and RIMS in general terms alongside Veeva Vault/RIMs and GMPS (Review and approval of Artwork components).

• Five years' experience as RA Officer at manufacturing plant ensuring life cycle management of products in terms of submission of variations, renewals, response to questions, new MAA, approval/post-approvals tasks, review and approval of Artworks, launch of products on local market, Sunset clause, management of archives and databases including preparation of eCTD dossiers/sequences preparation, publishing and submission. Experienced with Administrative, Safety and CMC changes related to drug products, and also managed preparation of dossiers and obtain their approvals for dietary supplements (vitamins, minerals and herbal dietary products).
• Compiled daily and monthly reports for RA activities, reviewing and approving SOP's and internal documentation from other departments (e.g. manufacturing or quality control departments).
• Kept track of all submissions/approvals from product portfolio.
• Preparation of presentations/reports for different topics and meetings planned for RA team including preparation and planning of budgets.
• Kept track of invoices related to RA activities, for these to be correct and payment to be done in due time while also preparing reports of costs per month/year.
• Provided support and training to other colleagues from other departments for databases and activities related to RA department.
• Part of team responsible for implementation of EU Falsified Medicine Directive at manufacturing plant and part of Group 5 Pilot of Romanian National Medicine Verification Organization - OSMR representing.
• Experience with Track Wise system for initiation of change controls triggered by RA department and Regulatory Change Control Assessments.
• Worked with AMS (Artwork Management System) for managing review and approvals of Artworks and EDMS system for review and update of SOPs.

• Answered questions and helped pharmacy customers locate desired items.
• Checked inbound pharmacy stock met quantities listed on delivery records.
• Worked under guidance of pharmacist to prepare compounds and dispense medications.
• Merchandised counters with attractive displays to increase pharmacy sales.
• Maintained organised work spaces to aid team efficiency in customer-facing environment.
• Worked under supervision of licensed pharmacist by shadowing, asking questions and responding to feedback.
• Collaborated with senior pharmacists, enhancing learning experience.

• Delivered exceptional customer service by addressing patient queries promptly.
• Helped establish comfortable environment for patients through empathetic communication.
• Worked closely with team during busy periods, ensuring high levels of service delivery despite increased workload.
• Collaborated with senior pharmacists, enhancing learning experience.
• Managed inventory effectively, reducing wastage whilst ensuring availability of necessary drugs at all times.
• Worked under supervision of licensed pharmacist by shadowing, asking questions and responding to feedback.