Experience

Pia Pharma Pty Ltd

• Australia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Associate

  • Feb 2018 - Present

   Constant interface with the global regulatory team and clients,  Evaluation of dossiers and development of regulatory paperwork related to registration, variations and renewals of products; Liaise with Australian and international regulatory bodies (TGA, APVMA, MAPA, ACVM, EU), Preparation of regulatory documentation – permit applications, product registration applications Preparation of import permits of products and active and non-active constituents, according to current law;



Pfizer

• Events Services
• 1 - 100 Employee

• Regulatory Affairs Analyst Senior

  • Oct 2014 - Jan 2018

   Constant interface with the global regulatory team in the US, to clarify local requirements and request documents (eCTD, CMC submissions); Support coordination and management in Regulatory Affair activities. Responsible for regulatory assessments for proposed projects in Pharmaceutical products (in charge of Advil®), Food Supplement (in charge of Centrum®) in order to prepare the documentation and regulatory strategies to support variation for approved products and evaluate the project´s feasibility until its launch. Attending the global meetings regarding the projects updates to keep tracking the timelines; Area representative in internal meetings with Business Development and Market Intelligence teams for regulatory evaluation of projects, including analysis of competitors; Analysis of dossiers and development of regulatory processes related to registration, variations and renewals of pharmaceutical (mainly OTC) and nutritional products (food supplements); Analysis and update of labeling texts, based on CDS and other core documents; Submission of Good Manufacturing Practices; Evaluation of promotional material and training with the Marketing team; Research and analysis of database for regulatory intelligence; Preparation and review of standard operational procedures of the area; Regulatory support to others departments (Quality, Supply Chain, Sales team, Artworks Development); Preparation of processes related to the import of products and raw materials (including those subject to special control) according to current law; Participation in meetings with BoH (ANVISA) for clarification of requirements and processes; Active participation in pharmaceutical trade associations.



Galderma

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Analyst

  • Jan 2011 - Sep 2014

  • Development of processes related to registration and compliance with requirements of medicines (New Drugs and Branded Generics), cosmetics (Grade 1 and 2), and health products (equipaments and material for professional use);• Preparation of dossiers for regulatory support INMETRO certification;• Evaluation of promotional material and training related to current legislation;• Support to the Sales, Marketing, Quality, Suply Chain Departments;• Accompaniment audits of GMP• Participation in meetings with ANVISA;• Active participation in professional associations, as Interfarma, Sindusfarma and ABIMIP.

• Quality Trainee

  • Aug 2010 - Dec 2010

  • Accompaniment in external and internal audits;• Comprehensive knowledge in quality documentation and manufacturing;• Support in release of products, products return and customers complaint;• Cadastre of structures in the Protheus System.