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REGULATORY AFFAIRS Analyst Consultant at ClinChoice. Location Information: . Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….. . ClinChoice is searching for a . Regulatory Affairs Associate Consultant.  . for 12 months Contract with possibility of extension . to join one of our clients.. . ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  . . . . . . Job Title. . . . ANALYST REGULATORY AFFAIRS Consultant. . . . . . Job Summary. . . . Ensures proper submission and approvals for market licenses including new registrations, changes and timely renewals, and establishment registrations, organizing and balancing a multitude of projects simultaneously.. . . . . . Scope. . .  . . . . . Major  Roles and Responsibilities. . . . . 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. . . . . . . Experience/ Qualification  Requirements. . . . . Must have 1-2 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for Brazilian Health Authorities and a successful track record.. . Desirable experience in Medical Devices or Pharma background.. . . . . . . Education Requirements. . . . ·       A Bachelor’s Degree in Engineering, Pharmacy or other life science: Can be a person with related experience and/or training or equivalent combination of education and experience. Advanced reading and writing Skills in English are required; intermediate to advanced speaking is desirable. Fluent in Portuguese.. . . .