Vagas para analista Jr e coordenador de Assuntos Regulatórios - São Paulo

Pfizer

Coordenador Assuntos Regulatorios

- Coordinate the actions related to submissions of new product registration, line extensions, post-approval changes/History Product Changes and License Renewals for all Pfizer's Established Products.

- Interact with LATAM Regional Growth Hub and LATAM Regional Lifecycle Team to ensure the dossier deliverable on new product registration, line extensions, post-approval changes/History Product Changes and License Renewals (including query responses) according to BoH requirements as well as within agreed timeline for regulatory submission;

- Review all the documents and dossiers related to submissions of new product registration, line extensions, post-approval changes/History Product Changes and License Renewals, ensuring that dossiers to be submitted fully meet the local regulatory requirements. - Interact with LATAM Regional Growth Hub and LATAM Regional Lifecycle Team in order to ensure elaboration of packages inserts of new products, as well as update the current package inserts according to international documents received from the Headquarter and Global SOPs.

- Participate in meetings at Trade Associations (INTERFARMA, SINDUSFARMA, and others) and other agencies related to Drug Registration/Post Approval Changes.

- Keep updated on the latest changes to the legislation.

- Support bidding processes by providing updated regulatory documents.Coordinate the activities with the team in order to keep updated the information related to regulatory documentation on Pfizer’s Brazil intranet to support key other stakeholders activities on bidding and importation processes. - Perform all trainings required for the position.

- Contact Health Authorities by elaborating documents, e-mails, phone contacts and meetings for following-up processes of registration approval.

- Collaborate and establish a network with business partners and stakeholders. skills:Technical

Good knowledge in sanitary legislation related to products registration and related subjects.

Good technical-scientific knowledge of pharmaceutical products.

Good knowledge in English language.

Managerial

Customer-oriented;

Results-oriented;

Negotiation;

Planning;

Organization and control;

Decision making;

Communication;

Development of people.

A Pfizer promove a igualdade de oportunidades no trabalho cumprindo com a legislação aplicável neste âmbito, em todos os países em que está representada.

Candidate-se!

 

Analista Assuntos Regulatórios Jr.

Interact with LATAM Regional Growth Hub and LATAM Regional Lifecycle Team in order to elaborate and review the package inserts of new products, as well as updating the current package inserts, according to international documents received from the Headquarter and local SOPs.
Interact with LATAM Regional Growth Hub and LATAM Regional Lifecycle Team to perform procedures for layout approval of package materials and labeling artwork for submission purposes and implementation on the market.
Follow-up at ANVISA’s website on product registration, line extensions and post-approval changes.
Keep updated on the latest changes to the legislation.
Keep updated internal tracking tools related to registration activities.
Keep updated information related to regulatory area on Pfizer’s Brazil intranet.

Perform all trainings required for the position.

Skills

Technical

Knowledge in sanitary legislation related to products registration and related subjects.

Technical-scientific knowledge of pharmaceutical products.

Good knowledge in English language.
Managerial

Candidate-se!