Analyst Regulatory Affairs
2 semanas atrás
**Job Function**:
Regulatory Affairs Group
**Job Sub Function**:
Regulatory Affairs
**Job Category**:
Professional
**All Job Posting Locations**:
São Paulo, Brazil
Main 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 JJ 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 implementation and regulatory assessment of new regulations.
- Elaborate procedures of the area.
- Organize team meetings and elaborate agenda and minutes.
- Manage quality issues.
- Manage compulsory certification and GMP activities.
Qualifications:
- 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
- Bachelor’s Degree in Engineering, Pharmacy or other life science
- Knowledge of Local & International Regulation and Processes
- Analytical capability and investigative skills
- Prioritizes work to meet deadlines, sense of urgency
- Advanced level of English
- Desirable experience in Medical Devices or Pharma background
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