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. |
| GLP Behaviors | * Collaboration and teaming * Results & Performance Driven * Sense of Urgency |
| 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. |