Associate Director, Program Management, Launch Execution

• May 2022 - Present

Senior Program Manager

• Jan 2020 - Apr 2022

Program Manager

• Oct 2018 - Dec 2020

Global Program Manager

• Jul 2015 - Oct 2018

- Management of 18 Global Programs and overall budget of over 20MEUR, pro-active management of key deliverables and synchronization between key activities (work packages) in order to ensure on-time on-costs delivery of new products.- Support overall projects execution and resources allocations by providing continuously updated information regarding programs' timing, costs and quality, mitigation of time & costs slippage - Building of optimized Global Program Plan (GPP) for the Global Programs of the Sanofi Gx Division and update of the GPPs along the Program life cycle

Product Launch Manager - Sanofi Gx Global Division

• Nov 2013 - Jul 2015

• Responsible for planning and project management of Global Projects at Gx Division level for in-licensed and in-house products to ensure a successful launch• Benchmarking and challenging - in cooperation with Regional Launch Management, Commercial and other expert functions - actual timelines of launch preparation activities with planned timelines and identify opportunities for acceleration of launches or identify potential launching delays• Communication management regarding the launch plan to ensure all teams are aligned and have required information• Working in partnership with In-Licensing, Supply Chain, External Supply, Manufacturing, Quality Regulatory and other functions enabling support elements, to meet critical timelines and ensure product availability for day one of the scheduled launch• Identification and communication of potential risks in the launch plan, contributing to potential solutions• When required, management of external vendor relationships related to project management • Integration of LatAm and Asia-Pacific regions into Global Gx Division, which includes implementation, management and monitoring of the launch processes for Generic products • Project support for already integrated EU region, close cooperation with Regional EU Launch Manager• Support and input for launch planning to all regions for Budget and LRP preparation purposes• Support with preparation of presentations to Sr. Management (as required)• Coordination of reporting processes between Countries, Zones, Regions and Global Gx Division

Regulatory Zone Manager - Africa region

• Nov 2012 - Jan 2014

• Responsible for set up of appropriate regulatory strategies for submissions in Africa • Responsible for coordination of various activities to ensure timely submissions and delivery of Marketing Authorizations (preparation of M1 dossier documents, samples ordering, dissolution profiles ordering, Sourcing Case tracking, Territory Extension Process coordination), as well as consequent life cycle management and product maintenance • Established effective coordination of all regulatory activities in the region (including affiliates, manufacturing sites, development centers, external partners) and support of Prague teams

Head of Project Management

• Oct 2009 - Oct 2012

Accountable for DCP/MRP and RT project teams. Responsible for organization of resources necessary to deal with the variety of registration commitments being worked on and planned for (internally as well as outsourcing). First point of contact for key clients as well as managing their projects.Manage team of 25 Project Managers across EU and India. Help PMs with ongoing projects, as well as with long-term improvement of their skills, enabling them to fulfil their potential within the organisation. Setting objectives and evaluating PMs performance on a regular basis.Conduct and arrange on-the-job training for new hires. Prioritize and establish schedules to complete assignments and ensure that plans are consistent with clients’ requirements and timescales.

Senior Project Manager - Regulatory Affairs

• Sep 2008 - Oct 2009

Successfully managed several initial MAAs using Decentralised and Mutual Recognition Procedures including module 1 preparation and national phase coordination, RMS and CMS liaison, variations and post-approval work including: labeling, linguistic review management, artwork sign-off, follow-up measures and renewals within the European Union are in accordance with EU directives, regulations, guidelines, national requirements and company policies and procedures.Communicated with regulatory health authorities when required in an efficient and professional manner and built a network of Regulatory contacts in the EU Health Authorities.Gained in depth understanding and practical experience of EU RA regulations, guidelines and working practices.Coordinated work for electronic submission (NeeS/eCTD) of registration dossiers.

Project Manager

• Feb 2006 - Sep 2008

Developed all testing processes and procedures for readability testing of patient information leaflets in ELC. Worked closely and liaised with MHRA/EU agencies frequently on readability testing strategies to ensure all testing requirements are met. Gained in depth understanding and practical experience of UK and EU RT regulations, guidelines and working practices. Responsible for communication with European authorities to interpret legal requirements and any changes in legislation. Managed all phases of PIL testing process e.g. writing and evaluating of the leaflet, preparing the questions for the interviewer and analysing the completed interview results, writing the final report for client’s and EU approval. Revised/created more than 600 PILs up to date. Managed more than 800 RT tests. Coordinated desktop publishing projects. Worked closely with DTP department and client on mock up design and creation. Recruited, trained and managed European team of Interviewers and Junior Project Managers.

Teacher

• Sep 1997 - Jul 2010

Private English Tutor- specialising in teaching EN as a foreign Language to kids and adults. Private English Tutor- specialising in teaching EN as a foreign Language to kids and adults.

PA and Project Coordinator

• May 2004 - Dec 2005

Develop a detailed understanding of the Supply chain Operation in Poland through Store and DC visits with the Supply Chain Director Provide complex verbal translation for Supply Chain Director, DC General Manager and other UK visitors to the site Manage language and written translation of company materials, within the supply and distribution teams, (for example handling instructions, operating manuals, product training, verbal translations etc). Liaise with Assistants in the UK and develop schedules for visiting Directors and Managers to Poland and Central Europe. Manage suppliers issues, co operate with supply chain department in Krakow and report to Supply Chain Director.

Senior Teacher

• Jul 2002 - May 2004

Teaching english at all levels (private and state schools). Responsible for employing and training of new teachers for the company. Teaching english at all levels (private and state schools). Responsible for employing and training of new teachers for the company.