ClinChoice
REGULATORY AFFAIRS Analyst Consultant
Brazil · Work style not stated
Posted over 6 months ago: check it’s still open
Apply on the employer’s site ↗See how well you match this job
You apply directly with the employer. ROLIVA does not submit applications from this page and is not the employer.
About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerClinChoice
- LocationBrazil
- Work styleWork style not stated
- Employer posted
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 Consultantfor 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.
Show full description
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.
Check your resume against this job Free, no sign-up. Nothing you paste is stored.
Staying safe while you apply
- Never pay to apply, interview or accept an offer. ROLIVA never asks you for payment to apply to a job.
- Apply only through the official “Apply on the employer’s site” button, on the employer’s own site, and check that a recruiter’s email uses that employer’s own domain rather than a free email address.
- Be cautious of an offer made with no real interview, or pressure to decide quickly or share financial details early.
Does something look wrong with this listing? Use “Report broken link” in the role details, or read ROLIVA’s full job-safety guidance ↗.
Preparing for this role with ROLIVA
- Check the fit.
Compare the requirements with the experience you have confirmed, including gaps.
- Prepare honestly.
Build interview stories and application drafts from your own evidence.
- Keep track.
Save the role and record your own application status and follow-ups.
At a glance
- Employer posted
- Added to ROLIVA
- Last checked