REGULATORY AFFAIRS Analyst Consultant

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

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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.

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• 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

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• 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.