Hellen Lima Email & Phone Number

Brazil

- Experience in manage planning and scheduling (team timelines and deliverables) with multidisciplinary teams (Marketing, Production, Regulatory assurance, Quality, financial area, among others) using project management tools (ie MS Project).- Experience in create a timeline analysis to highlight inconsistencies, scheduling conflicts, and gaps in asset models compared to scheduling standards and to promotes a development of risk assessments, creation of risk mitigation plans and define the project team and governance structure.- Experience in CMC (Chemistry, Manufacturing and Controls) evaluation and management, products life-cycle management, post-approval changes, new products feasibility evaluations.- Leadership of project teams, interpersonal relationship, proactive posture, dynamic, organized and committed. Ease of adaptation to new environments and functions.- Monitoring of schedules to meet the scope, costs, resources and deadlines agreed. - Management of the possible risks reporting to the team and guiding those responsible to minimize impacts on the schedule and issuing project information (schedules, meeting minutes, reports, performance indicators) to the team, leader, sponsor and stakeholders of the project and management team of the company.

São Paulo, Brazil

- Member of the strategic due-diligence group aiming at acquisitions of new businesses. Performed technical-regulatory adaptations of international dossiers aiming at regional submission. In this project I was responsible to make feasible submission of generic and similar drugs dossers for registration in Brazil, through data and regulatory strategy. I have established, in an innovative way in the company, the systematic technical, regulatory analysis and the action plan for submission in accordance with local regulations.- Responsible for India (Kalwe) and Austria (Kundl) Sandoz sites for maintaining the portfolio and Registration, Post-Registration and Renewal Generic, Similar and Innovated Medicines; Response to deficiency letters in accordance with local requirements; Planning and elaboration of Annual Report; Risk assessment, review, approval and notification of changes in processes that involve the Change Control routine; - Reviewed and technically evaluated drug master file (DMF) of active pharmaceutical ingredients for submission against the new regulatory framework of API (CADIFA); - Dossiers for registration and post-registration of generic and similar drugs in CTD format.- Submitted registration renewals, annual reports (HMP), submission of periodic benefit-risk report (PSUR), package inserts and labeling for generic, similar and clone drugs.- Contemplated interface activities matrix to plan and respond to drug registration and post-registration requirements, using globally defined tools for documentation preparation and with the medical, marketing departments to evaluate and approve of advertising materials. - Evaluated change control, using tools defined globally to prepare documentation, in order to ensure any change with regulatory impact was fully carried out in accordance with current post-registration legislation.

São Paulo, Brazil

- Responsible for the registration submission strategy for a similar drug, applying regulatory intelligence and supporting the successful registration and marketing approval.- I was in charge to interface activities with the departments of quality control, quality assurance and affairs, project manager and research and development, aiming to meet the requests of regulatory agencies such as ANVISA and the feasibility of registration and launch of new products.- I performed to review the documentation necessary for registration and post-registration to ANVISA analytical validation reports, drug master file (DMF), pharmaceutical technology report, technical file, production process risk assessment, stability report, bioequivalence protocol and pharmaceutical equivalence reports.

Paraná, Brazil

- Responsible for reviewing the dossier and action plans for risk mitigation of the company's first export project documentation, in accordance with FDA regulations, official compendiums, national legislation and international guides, cooperation the successful approval of the registration and marketing of it.- Contemplated interface activities with the quality control, quality assurance and regulatory affairs departments, aiming to meet the requests of regulatory agencies such as Anvisa and FDA.- I was in charge to review the analytical validation reports, analytical methodology for raw materials and finished product and technical support to the development team for the development of new analysis methods.- Responsible for preparing the Company Technical Assessment (PATE) was originated in the Research and Development area, in addition to participating in the multidisciplinary team formed to assess the changes, framed it and submitted the PATE document to ANVISA.

São Paulo, Brazil

- I was in charge for 15 projects for the development of parenteral solutions of large volume, and blood transfusion bags; improvements in production processes and in the export of blood bags in Latin America, resulting in an increasement of the company's synergy, improving the portfolio with new releases.- Had experience in interface activities with the departments of new business, export and purchasing, activities for preparation and analysis of the business plan, prospecting for new partners, qualification of new raw material suppliers, process improvement and technology transferring.- I performed activities of drug master file (DMF) review, pre-formulation study, development and validation of analytical methodology for raw material and finished product, preparation of manufacturing scripts, stability study, preparation of the national registration dossier, response to technical requirements and needs for the export of blood bags in Latin America.

São Paulo, Brazil

- I was in charge for the interface activities with the departments of new business, exportation and purchases for the elaboration of the business plan, prospecting for new partners, qualification of new raw material suppliers, process improvement and technology transferring.- Performed with the management of customer portfolio analysis and technical planning and visits to strategic customers, in order to assess the performance of the sales representatives, in addition, assist and monitor the process of standardizing new products in hospitals with the hospital infection control commission and study of inventory plan of distributor customers and presentations to customers in order to find opportunities and improvements.- Implemented marketing and new business dashboards and management reports for executive committee and board council meetings supporting the decision-making process.- I improved the portfolio, increasement of the company's synergy with new launches and establishing new partnerships for new registration of parenteral solutions of large volume and blood transfusion bags; improvements in production processes and the exportation of blood bags in Latin America.- Developed and performed training as well as preparation of technical documentation for the products in the portfolio, applied to the sales force and technical teams of nurses and pharmacists in public and private hospitals and participation in the annual marketing and sales plan.

São Paulo, Brazil

.

São Paulo, Brazil

.

São Paulo, Brazil

.

São Paulo, Brazil

.

São Paulo, Brazil

.

São Paulo, Brazil

.

Postgraduate Degree, Project Management

Bachelor Degree, Pharmaceutical Sciences

High School, High School