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Work experience


My experience at Regulatory Affairs area, has been, as main objective, to assure the quality on pre-registration, register and post- registration reports for the local and international Regulatory Agencies, to comply with established procedures and timetable upon specific job instructions of regulatory affairs and local legislations. In this regards, I have significantly contributed to keep and increase the portfolio of products in the companies I worked for, throughout the following activities:

  • Co-ordination and registration process elaboration and post-registration alterations and inclusions in medicines process (new, similar, generic, biologic, specific, herbal, OTC & prescription drugs, cosmetics, food and medical devices at Ministery of Health;

  • Compliance of Demands(Warning Letters) and legal remedies;

  • International registration dossiers: translation, manage and sending of international technical-scientific documentation of the products; contact with international areas in order to obtain regulatory information/documents.

  • Support Quality Assurance trough elaboration / revision / conference / training and compliance of SOP´s;

  • Support on elaboration of contracts for outsourcing;

  • Development of data base for regulatory affairs dept management;

  • Elaboration and issuance of monthly and quarterly reports for controlled substances and related process (Permission to acquisition, FunctioningLicences and Registration Certificates) on Federal and Civil Police and Army;

  • Protocol and follow-up of process development on ANVISA management through follow-up meetings and registration pending;

  • Follow-up and update of regulatory status, evaluation of new legislation impacts on the other involved areas, when required;

  • Follow-up and development control of bioavailability/bioequivalence tests of generic and similar drugs, on centers licensed by ANVISA (REBLAS);

  • Attendance on meetings for associations and entities of the category (Febrafarma, Sindusfarma among others) to exchange information related to the area;

  • Evaluation and approval of publicity material (medical and consumer advertising) and packaging according to the legislation in force;

  • Follow-up of and support in purchasing and supply qualification, internal auditories,auto-inspectionsand governmentalinspectionson ANVISA and VISA local and other certifications (Good Practices, Authorizations and Functioning Licenses, etc).

Activities developed as Pharmacist in charge and in SAC/Pharmacosurveillance:

  • Representation of company on ANVISA, CVS, VISA and remaining regulatory agencies;

  • Monitoring and controlled medicines flow;

  • Follow-up of Quality System of the Company, as well as production, storage and distribution activities according to RDC nº 210/03;

  • Follow-up of complainings mentioned through the SAC/Pharmacosurveillance: change of complaint products, investigation of no-compliance with support of Quality and Control Assurance and causality of adverse events reported by consumers.


IPH – Instituto de Desenvolvimento e Pesquisas Hospitalares

  • Pos-graduation (specialization) in Clinical Pharmacology

Start: mar/2006

Conclusion: may/2007

USP – Universidade de São Paulo

  • Pos-graduation (specialization) in Production and Drugs Quality Control

Start: aug/2004

Conclusion: aug/2005

UNIP – Universidade Paulista

  • Graduation: Pharmacy & Biochemical

Start: jan/1998

Conclusion: jan/2003


  • English: fluent

  • Spanish: intermediate

Information Technology

  • MS Office (Word, Excell, Power Point)

  • Windows, Internet, Html, Outlook, Outlook express, Lotus notes; Acrobat; Page Maker

Extra Courses
  • Validation of Pharmaceutical Industry Process – Febrafarma 2002

  • Procedures of ANVISA applied to International Trade – Febrafarma 2002

  • Elaboration of outsourcing contracts – Febrafarma 2003
  • Stability of drugs and medicines – Febrafarma 2003

  • European Pharmacopoeia – Febrafarma 2003

  • Clinical Toxicology – Clínica´s Hospital (Ceatox) 2003

  • I Seminay of Transportation of Medicines – CRF/SP 2007

  • Ken Blanchard Leadership – Febrafarma 2008


LUPER Pharmaceutical Industry

Time Period: March/08 to January/09

Roles and responsibilities: Supervisor of regulatory affairs and pharmacosurveillance service


Time Period: June/07 to March/08

Roles and responsibilities:

- Supervisor of regulatory affairs (corporative) for the companies: Inpharma (drugs industry), Pharmabag (medical devices company), Phyton Fórmulas Magistrais e Oficinais (manipulation pharmacy of parenteral nutrition and quimioterapy), Pharmacia Artesanal (drugstore) e Essenca Produtos Médicos e Serviços Ltda. (medicines,cosmetic, food and medical devices distributor)

- Pharmacist in charge (Technical Responsible) for Essenca Service and Medical Devices distributor.

PRODOTTI Pharmaceutical Laboratory

Time Period: July/06 to June/07

Roles and responsibilities:

- Coordinator of regulatory affairs for the companies: Nutrícia (food industry), Cirubrás (medical devices company) and Sintomed (drugs industry)

- Pharmacist in charge for lab Prodotti

LATINOFARMA Pharmaceutical Industry

Time Period: Jan/06 to Jun/06

Function: Regulatory affairs Supervisor


Time Period: Jan/05 to Dec/05

Function: Regulatory Affairs Analyst

ROCHE Chemichal and Pharmaceutical Products

Time Period: Mar/04 to Dec/04

Function: Regulatory Affairs Assistant

Time Period: Aug/02 to Mar/04

Function: Regulatory Affairs Assistant Jr

Time Period: Nov/00 to Jul/02

Function: Regulatory Affairs Trainee

DRAGOCO Fragrances and Flavors

Time Period: Nov/99 to Nov/00

Function: FragrancesDevelopment Trainee

Activities Developed:

  • Balance and preparation of fragrances: personal hygiene, cosmetics, perfumes and sanitizing products, for tests on fragrance application lab;

  • Raw Material inventory control.


Aug 2004Aug 2005

Pos-graduation (specialization) in Production and Drugs Quality Control and Clinical Pharmacology

USP - São Paulo University/ IPH - Institute of Development & Hospital Research



Regulatory affairs leader (Supervision/Coordination/Management)


Please find attached my resume for your appreciation.

I am looking for new challenges within chemical-pharmaceutical, cosmetic, food and medical device segments.

I bring to this position over 8-year experience at Regulatory Affairs area, of which 5 years working in international companies as Roche and Bayer. One of my acquisitions during my career were the first register of food obtained at Roche and the first switch of Brazil what meant the permission of Health Authorities to sell the medicine Flanax as OTC product (over the counter).

I have a degree of Pharmacistand Biochemical, with pos-graduation in Drugs Quality Control and Production and Clinical Pharmacology.

Leadership, dynamism, results-oriented, pro-activeness and strategic mind-set are my main competencies, besides good interpersonal relationship skill and facility of adaptation.

Match the profile, leading team for 3 years, fluency in english, availability of moving city/state and travellings.

My previous position was as a Supervisor of Regulatory Affairs and Pharmacosurveillance Service in a Brazilian pharmaceutical company earning 5.000 reais per month. This company needed to cut the expenses of this vacancy and fired me in january/09.

I would like to thank you in advance regarding this subject and remain at your disposal to discuss how my skills and experiences fit well in your organization.

Personal references

- Giovane Bastos (Managing Director – Luper)

- Claudio Mozzelli (Comercial Manager - Luper)

- Flavia Ladeira (Corporative Quality Manager - EMEDE/Farmoterápica Group)

- Suzana Gasquez (Manager Industry - Prodotti)

Sincerely yours,

Vanessa Cavalcanti da Cruz

Mobile: (11) 9195-9122