Job summary:

- 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

Job responsibilities:

- 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).
- Elaborate processes related to exportation documents.
- 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.
- Keep updated information related to regulatory area on Pfizer’s Brazil intranet.
- Perform all trainings required for the position.

Qualifications:

- Education: Pharmacist
- Experience: 2 years as Regulatory Affairs Analyst

Technical Skills:

- Technical-scientific knowledge of pharmaceutical products;
- Good knowledge in English language.

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

LI-PFE