REGULATORY AFFAIRS Analyst Consultant

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.