ClinChoice - REGULATORY AFFAIRS Analyst Consultant

• Elaborate regulatory strategy and execute submission of changes, new registrations and renewals in timely manner with some guidance. • Execute activities to obtain or update establishment registration licenses. • Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates. • Request and follow-up of documentation to prepare registration dossiers. • Supports regional team on product submissions schedules, prioritization, and pipeline management. • Support internal and external audits with documentation requests. • Interacts with other stakeholders, government agencies in a professional, decisive, & articulate manner. • Act as a point of contact for stakeholders to support business plans and regulatory needs. • Review labels compliance in internal system. • ·       Support projects as representative of the subject/country. • ·       Elaborate procedures of the area. • ·       Organize team meetings and elaborate agenda and minutes. • ·       Manage quality issues. • ·       Manage compulsory certification (INMETRO) and GMP activities. • Competencies • Knowledge of Local & International Regulation and Processes • Analytical capability and investigative skills • Self-motivated and committed to a team approach • Communicates clearly and effectively. • Prioritizes work to meet deadlines • Planning and Organizing skills • Understands the importance of the adherence to compliance • Project Management skills and ability to manage complex data with excel spreadsheets are desirable • GLP Behaviors • Collaboration and teaming • Results & Performance Driven • Sense of Urgency • Integrity & Credo-based Actions • Intellectual curiosity • Self Awareness & Adaptability