Ariana Sanches Fonseca Email & Phone Number

Riverview, Michigan, United States

✔ Preparation and review of documents such as CMC, IND, NDA, MAA, DMF, Annual Review, Amendments and Supplements in compliance with applicable regulations established by FDA, OSHA and EPA;✔ Preparation and review of Validation Reports and Process Performance Qualifications;✔ Review proposed product changes for impact on regulatory status of the products;✔ Provide regulatory guidance and support for development and production activities;✔ Development and preparation of regulatory reports for submission to the regulatory bodies;✔ Interact with auditors, regulatory bodies, customers and investigators.

Chesterfield, Michigan, Usa

- Conciliating Batch Records by reviewing all production and quality control paperwork, verifying the compliance with Food Safety requirements, and approving the final product release;- Uploading all production records on SAP/WMS System and generate management report with weekly or monthly summary of production numbers, such as finished goods, yeld, waste, hold materials, labor and costs;- Inspecting and performing physico-chemical tests on raw materials, in-process and finished products ensuring regulatory compliance and maintaining adherence to required standards and specifications. - Reviewin, and updating procedures, policies and Food Safety library according to SQF requirements.- Actively participating of problem mitigation on production environment, by providing technical expertise and guidance in order to enhance profitability and process efficiency;

Greater Detroit Area

Relocated from Brazil to the US, took a career break to facilitate adjustment, focused on assisting family in this international transition.

São Paulo, Brazil

Preparing Drug Clinical Development Dossier (DDCM) reports for ANVISA approval previous to run Clinical Trials;

São Paulo Area, Brazil

- Running project feasibility analysis and regulatory strategies;- Preparing expert opinions to comply with requirements and file appeals against regulatory authority denials;- Preparing Drug Clinical Development Dossier reports for ANVISA approval previous to run Clinical Trials;

São Paulo Area, Brazil

 Reporting to the Regulatory Affairs Division, leading 4 employees; Leading the technical-regulatory committee, and performing critical analysis of new projects, post-registration change projects, product adequacy and redevelopment, identifying opportunities in current legislation and establishing the required actions to make such projects viable; Designing the regulatory strategy to ensure company portfolio maintenance in compliance with current health requirements, and managing team activities and negotiating deliveries and deadlines with related technical areas; Assessing and enabling projects, performing regulatory due diligence, with successful experience in new business, culminating in company portfolio increase, with the health regulation of the first products in the following categories: food supplements, cosmetics and healthcare products (correlated); Political skills, maintaining close relations with class associations (Sindusfarma / Alanac) to discuss regulatory issues and participating in committees for active negotiation with ANVISA; Building on close relations with main ANVISA stakeholders and related entities, reducing obstacles to advocate company interests; Controlling the intellectual property process for brands and patents at INPI; Managing strategic regulatory information, having structured a process to monitor on a daily basis the industry’s main media, identifying legislations, tends and publications relevant to the company operations, assessing impacts and establishing adjustments, as applicable; Restructuring processes and procedures for the regulatory area, improving preparation criteria, reviewing and conducting critical analysis of dossiers and eliminating potential vices in activity development, generating 22% increase in team performance; Implementing the guidelines for promotional material preparation and approval, resulting in deadline shortening and compliance increase, according to risk criteria.

São Paulo Area, Brazil

 Reporting to the Regulatory Affairs Director, leading 4 employees; Responsible for implementing Latin America expansion of the company, structuring and leading regulatory teams in countries as Argentina, Bolivia, Chile, Uruguay and Venezuela; Planning and managing international registration processes, with strict monitoring of activities of Latin-American affiliates and other international partners, guiding the adequate registration process customization and requirement compliance; Studying the health legislation of different countries in Latin America, Africa and Asia, conducting the feasibility analysis of new projects, providing strategic recommendations and managing the new registration implementation plan in those new markets; Managing active pharmaceutical ingredients (APIs) registration, national and international GMP certifications and maintaining health authorizations/licenses of all business units, controlling about 10 different plants; Strict interface with Quality Assurance, in order to obtain national and international Good Manufacturing Practices (GMP) certifications, running auto-inspections, filing all quality documents required by health authority, and reviewing all validation procedures previous to GMP inspection.

São Paulo Area, Brazil

INTERN to SENIOR REGULATORY AFFAIRS ANALYSTManaging, obtaining and adjusting authorizations, operations licenses and certifications of GMP of the company’s 5 manufacturing plants, with strong performance at ANVISA and local Health Surveillance Departments;Responsible for the health regulation for the design of Eurofarma’s Industrial Complex in Itapevi, including facilities adjustment, inspection monitoring, negotiations with health authorities, GMP certification and product registration change management;Preparing and reviewing registration processes, changes, renewals and compliance with requirements for drugs, healthcare products, cosmetics and animal health products;Preparing, adjusting, reviewing and approving drug package-insert texts, labeling and promotional materials;Monitoring and providing statistical treatment of processes timeline, requirements and ANVISA approvals, generating managerial performance and market monitoring reports;Company representative at the relevant bodies of the health authorities and other entities and associations relating to regulatory aspects;Technical assessment of the health feasibility to implement new processes.

São Paulo Area, Brazil

- Expertise in physico-chemical, metallographic and optical microscopy analysis, by inspecting and approving raw material, in-process supplies and finished products;- In charge of the metrology system by controlling, checking and calibrating all measurements equipment used in production, as well as studying and doing the statistical control of the measurement systems.

São Paulo Area, Brazil

- General routine in quality control laboratory by monitoring raw materials, semi-finished and finished products, performing physical and chemical analysis by gravimetry, volumetry, spectrophotometry and rheometry;- Highly strict quality environment, immersed in Japanese quality tools such as Kaizen and 5-S.

Certification, Regulatory Affairs Certificate: Pharmaceuticals

Regulatory Affairs Certificate Pharmaceuticals is achieved by completing four core and five elective courses. Core courses: Ethics, Global.

Master Of Business Administration, Executive Mba – Pharmaceutical Industry

Bachelor Of Pharmacy - Bpharm, Industrial Biochemistry Pharmacy

Chemical Technician