We are Visanco, a consultancy specialized in regulatory affairs that focuses on the registration and regulatory compliance of companies and products subject to health surveillance.
We have a highly qualified team united in our mission to provide the best technical and strategic solutions for the healthcare sector.
The Regulatory Team in the pharmaceutical area works with Medicines, Pharmaceutical Ingredients, Cannabis Products, Biological Products, Clinical Research, Medical Devices, Cosmetics, Disinfectants and Tobacco-derived Products.
Requirements
Academic background: Pharmacy
Experience in Regulatory Affairs for products subject to ANVISA’s sanitary control, including:
Pre-registration measures, registration petitions and post-registration activities;
Applicable legislation and regulatory strategies;
ANVISA administrative and technical procedures;
Assessment of registration/notification feasibility for medicines;
Evaluation of clinical studies and/or literature to demonstrate safety and efficacy;
Analysis of specifications, analytical methodologies and validations;
Analysis of stability studies and tests conducted in accordance with relevant technical standards;
Preparation and submission of CBPF (Certificate of Good Manufacturing Practices) applications.
Proficiency in formal written and spoken Portuguese;
Excellent reading comprehension and text interpretation skills in Portuguese and English;
Advanced English (fluent in reading, writing, listening and speaking);
IT: proficiency with the Windows operating system and Microsoft Office (Word, Excel, PowerPoint and Outlook) and all ANVISA systems.
Benefits
Education and professional development assistance;