Analyst Regulatory Affairs - Fixed-term (12 months)

Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
São Paulo, Brazil
Job Description:

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.

• Lead projects or 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 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