C
REGULATORY AFFAIRS Analyst Consultant
Contract type
One-time
Work mode
Remote
Experience
Mid-level · 2+ years
Job description
A 12-month contract (with possible extension) as a Regulatory Affairs Associate Consultant, working directly for one of ClinChoice's clients. The role ensures proper submission and approvals for market licenses, including new registrations, changes, renewals and establishment registrations.
At a glance
- Employment
- Contract
- Work mode
- Remote
- Languages
- English – Advanced reading and writing required; intermediate to advan, Portuguese – Fluent
What you'll do
- 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
- Support regional team on product submissions schedules, prioritization, and pipeline management
- Support internal and external audits with documentation requests
- Interact with other stakeholders and 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
What we're looking for
- 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
- 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
- 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
- Fluent in Portuguese
Nice to have
- Project Management skills and ability to manage complex data with excel spreadsheets are desirable
- Desirable experience in Medical Devices or Pharma background
- Intermediate to advanced speaking is desirable
Apply
About ClinChoice
Global full-service CRO
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture.
Key facts
- Contract Research Organization (CRO)
- Global full-service CRO
- Strong focus on quality, professional development, and supportive culture
- Client-facing role
What they value
- Collaboration and teaming
- Results & Performance Driven
- Sense of Urgency
- Integrity & Credo-based Actions
- Intellectual curiosity
- Self Awareness & Adaptability