Assistente de Assuntos Regulatórios - Sao Paulo, Brasil - MSD

MSD

Empresa verificada

Sao Paulo, Brasil

há 3 semanas

Postado por:

Ana Silva

beBee Recruiter

Descrição

Main Responsibilities:

Acknowledge the Health Agency's organizational structure and the main legislation in force.
Acknowledge of international documentations: CTD, cBPF, CPP, CCDS, sMA.
Health Authority legislation followup updates and new legislation and impact evaluation.
Support in the evaluation of technical documentation received from Global and / or partners in accordance with current sanitary legislation.
Support in activities related to artwork development (requirements, procedures, traceability of developed artworks, legislation, update systems and metrics).
Support in the evaluation of the impact of the labeling update received from headquarter.
Elaboration, adequation and update of leaflet text and minibula.
Artwork and leaflet development (QRD elaboration and revision; artwork revision and approval)
Support in the elaboration of Response to Question (RTQ) for Health Authority.
Participation in Pharma Trade Association meetings and in departmental meeting.
Support in regulatory intelligence, if necessary.
Request for GMP certificate for Anvisa.
Elaboration and implementation of Standards Operational Procedures (SOP), when necessary.
Archive skills (organization and maintenance)
Keep the company's local and global regulatory systems up to date.
Support to the department's intern in monitoring official publications (e.g. Official Gazette, ANVISA webpage, etc).
General support for Exportation certification requisitions (CPP), when necessary.

Requirements:

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Education: Student of the health sciences, such as Pharmacy or Biomedicine.
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Languages: desirable English Business.
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Technological skills: MS Office (Word, Excel, Power Point)

LI-DNI

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Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

05/26/2024

Job Posting End Date:
05/26/2024

Requisition ID:
R296309