Leonardo Machado Martins

Outras informações:
Develop and implement regulatory/analytical strategic plans for PDP Pandora;Collaborate with internal/external partners to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and stretch goals;Develop effective working relationships with business partners and the authorities to support regulatory strategies;Provide regulatory guidance and input to external partners.Manage GMP sites submission renewals and queries, drive the regulatory compliance oversight focusing on ANVISA requirements and support RMC and LOC teams with initial certifications regarding variations and new submissions.

Outras informações:
Monitor the publication of new legislation, assess impacts, risks and opportunities and develop a robust plan for new legislation; Ensures compliance with regulatory agency regulations and interpretations; Post-registration changes/additions - assess regulatory technical impact, prepare and review highly complex submission documentation; Support the areas that generate change, with regard to the technical requirements of current legislation; Support the areas that generate change and propose solutions for more complex regulatory situations in an autonomous and proactive manner, being able to connect different concepts and impacts for the regulatory area; Autonomously carry out all regulatory activities related to registration petitions, exerting influence over the teams; Act as a focal point, in front of global, local and external teams such as Anvisa and class entities, through participation in Anvisa meetings; Review of technical documentation of the document management system aiming at regulatory compliance - high complexity; Documents, organizes and carries out changes in highly complex department procedures; Preparation and review of technical documents for new product registration, product renewal and HMP; Meet legal requirements, preparing and providing the necessary documentation, following the steps that involve the process until its regularization

Outras informações:
Activities related to validation and analytical method transfer to Brazil, elaboration and review of protocols and analytical reports, conducting investigations and evaluation of non-compliance results, participate and collaborate to the execution of regulatory strategic plans, remediation projects, contribute to projects for the introduction of new products in the market such as their impact assessment in the Brazilian market, manage the projects of the area participating in regional and global discussions, meeting the requests of the Business and providing support to the areas more too much in regulatory issues, quality and compliance.

Outras informações:
Preparation of technical documentation as: procedures, analytical methods, specifications,validation protocols/reports, qualification in various analytical techniques and projectcoordination, development of indicators of the area, support in national audits andinternationals as (ANVISA, COVISA, INVIMA, DIGEMID and Class Councils), critical technicalevaluation in relation to regulatory requirements, quality and Compliance, survey andmonitoring of materials and equipment for execution of projects and activities in externallaboratory partners and post-registration change activities.

Outras informações:
Analysis of finished product, raw material, validation, and co-validation of analyticalmethodology according to ANVISA standards, cleaning validation, process validation, stabilitystudy and pharmaceutical equival analysis. Instrumentation used: HPLC/UPLC (Waters) and CG(Agillent)

Outras informações:
Analysis of ophthalmic products, raw material, validation and co-validation of methodsaccording to ANVISA standards, dissolution profile, validation of electronic spreadsheets,preparation of procedures and general methodologies. Instrumentation used: HPLCAgillent/Shimadzu UV, infrared, CG, among others. Pharmaceutical equivalence studies for latersubmission to qualified centers for verification of equivalence prior to the official study, budgetsof study centers, organization of the study (verification of the need for samples, analyticalmaterials and sending them to the center), monitoring of the official analysis and conference ofthe report issued by the center.

Outras informações:
Monitoring processes, areas and equipment; analysis of quality indicators; assistance in thepreparation of dossiers for registration of health products; disposal control of products andmaterials; qualification of suppliers, customers, and carriers; ministry, training managecustomer recoveries and non-conformities; monitoring of import and inspection processes ofimported products. fix storage criteria, inspect the establishment, products and services; checkofficial balance sheets of controlled products; manage documentation (sanitary license,operating authorization, federal license and documentation of the technical area), preparationof manual of good practices, waste management and operational procedure. POP), manageinventories, cleaning management of the entire establishment, pest control and quality controlanalysis.