REGULATORY AFFAIRS Analyst Consultant

Job description

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. |