JOB RESPONSIBILITIES
- Perform activities related to initial dossier submissions and registration maintenance of company´s products, legal documents and/or systems.
- Supported, only if necessary. When required, participate in meetings with Anvisa, other Agencies and Trade Associations. Keep in touch with national PGS and Hubs in order to receive and provide the required support. Keep updated on the latest changes to the legislation.
- In partnership with the local PGS and LATAM Regional Regulatory Hub, evaluate data received from the Headquarter and other areas of the company for elaboration of technical reports.
- In partnership with the local PGS, Submission Hub and LATAM Regional Regulatory Hub, elaborate and review all the documents and reports required for the new registration process, line extensions, post-approval changes, license renewals and Product Changes History, according to the legislation in force.
- Ensure and prepare query responses of the ANVISA or other agencies, gathering all the necessary information and elaborating the process in partnership with local PGS, Submission Hub and LATAM Regional Regulatory Hub, when applicable.
- Interact with LATAM Regional Regulatory Hub in order to ensure elaboration of packages inserts and artworks of new products, as well as update the current package inserts and artworks according to international documents received from the Headquarter and Global SOPs.
- When required, participate in meetings with ANVISA or other Agencies, Trade Associations (Interfarma, Sindusfarma, and others).
- Follow-up at ANVISA’s website on product registration, line extensions and post-approval changes status.
- Keep updated on the latest changes to the legislation.
- Keep updated all Pfizer’s systems, share points and control spreadsheets related to all registration activities.

QUALIFICATIONS

Education

Pharmacist

Experience

2 years as Regulatory Affairs Analyst

SKILLS

Technical

Technical-scientific knowledge of pharmaceutical products.

Good knowledge in English language.

A Pfizer é uma das maiores empresas biofarmacêuticas de inovação do mundo e um dos valores da companhia é Equidade. Esta é uma oportunidade igualitária para todas as pessoas independentemente da raça, origem, gênero, orientação sexual, idade, presença de deficiência, estado civil, religião ou crença, nos termos da lei. Valorizamos a diversidade e inclusão, e buscamos um ambiente de trabalho cada vez mais plural, justo e equânime.

Regulatory Affairs

LI-PFE