REGULATORY AFFAIRS Analyst Consultant

<p></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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….</span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">ClinChoice is searching for a <strong>Regulatory Affairs Associate Consultant</strong>&nbsp;<strong>for 12 months Contract with possibility of extension </strong>to join one of our clients.</span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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. &nbsp;</span></p> <table width="699"> <tbody> <tr> <td width="135"> <p><strong>Job Title</strong></p> </td> <td width="564"> <p><strong>ANALYST REGULATORY AFFAIRS Consultant</strong></p> </td> </tr> <tr> <td width="135"> <p><strong>Job Summary</strong></p> </td> <td width="564"> <p>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.</p> </td> </tr> <tr> <td width="135"> <p><strong>Scope</strong></p> </td> <td width="564">&nbsp;</td> </tr> <tr> <td width="135"> <p><strong>Major &nbsp;Roles and Responsibilities</strong></p> </td> <td width="564"> <ul> <li>Elaborate regulatory strategy and execute submission of changes, new registrations and renewals in timely manner with some guidance.</li> <li>Execute activities to obtain or update establishment registration licenses.</li> <li>Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates.</li> <li>Request and follow-up of documentation to prepare registration dossiers.</li> <li>Supports regional team on product submissions schedules, prioritization, and pipeline management.</li> <li>Support internal and external audits with documentation requests.</li> <li>Interacts with other stakeholders, government agencies in a professional, decisive, &amp; articulate manner.</li> <li>Act as a point of contact for stakeholders to support business plans and regulatory needs.</li> <li>Review labels compliance in internal system.</li> </ul> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Support projects as representative of the subject/country.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Elaborate procedures of the area.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Organize team meetings and elaborate agenda and minutes.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Manage quality issues.</p> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Manage compulsory certification (INMETRO) and GMP activities.</p> </td> </tr> <tr> <td width="135"> <p><strong>Competencies</strong></p> </td> <td width="280"> <ul> <li>Knowledge of Local &amp; International Regulation and Processes</li> <li>Analytical capability and investigative skills</li> <li>Self-motivated and committed to a team approach</li> <li>Communicates clearly and effectively.</li> </ul> </td> <td width="284"> <ul> <li>Prioritizes work to meet deadlines</li> <li>Planning and Organizing skills</li> <li>Understands the importance of the adherence to compliance</li> <li>Project Management skills and ability to manage complex data with excel spreadsheets are desirable</li> </ul> <p>&nbsp;</p> </td> </tr> <tr> <td width="135"> <p><strong>GLP Behaviors</strong></p> </td> <td width="280"> <ul> <li>Collaboration and teaming</li> <li>Results &amp; Performance Driven</li> <li>Sense of Urgency</li> </ul> </td> <td width="284"> <ul> <li>Integrity &amp; Credo-based Actions</li> <li>Intellectual curiosity</li> <li>Self Awareness &amp; Adaptability</li> </ul> <p>&nbsp;</p> </td> </tr> <tr> <td width="135"> <p><strong>Experience/ Qualification &nbsp;Requirements</strong></p> </td> <td width="564"> <ul> <li>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.</li> <li>Desirable experience in Medical Devices or Pharma background.</li> </ul> </td> </tr> <tr> <td width="135"> <p><strong>Education Requirements</strong></p> </td> <td width="564"> <p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 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.</p> <p>&nbsp;</p> </td> </tr> </tbody> </table> <p>&nbsp;</p> <p></p> <p>&nbsp;</p>