Estágio de Assuntos Regulatórios

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
- A BMS acredita que ter uma equipe diversificada de funcionários e uma cultura de inclusão é vital para a inovação e para executar de forma bem-sucedida nossa estratégia de negócios BioPharma. _**_Todas as nossas oportunidades são abertas para pessoas com deficiência (PCD),_**_ assim como para as demais dimensões no sentido mais amplo da diversidade, como gênero, idade, etnia, raça, orientação sexual & identidades, habilidades físicas, aparência, religião, origem socioeconômica, estilos de pensamento e experiências de vida._
**Position overview**
The Regulatory Affairs area is strategic for the growth of the company. Through regulatory processes with ANVISA, the company expands and renews its portfolio. The regulatory environment is constantly changing, requiring companies to be ready to anticipate them, analyze their impacts, plan and implement them in a timely and effective manner. In addition, the Regulatory Affairs area is also responsible for ensuring that the company complies with the applicable health regulations in order to continue business, avoid penalties and protect the company's image. The Regulatory Affairs Intern should be prepared to work in this environment and deliver the expected results through teamwork, timely and quality under close supervision.
The position is in full compliance with BMS laws, regulations, policies and procedures, including business rules, as well as BMS Conduct and Ethics.
**Objectives/ responsibilities include, but are not limited to**:
Collaborate with the Regulatory Affairs team members in providing support to Brazilian submissions of registration renewal, HMP and regulatory low-mid complexity filings under close supervision. For low-mid complexity is considered (but not limited to)*:
- registration renewal
- HMP (History of Modifications to the Products)
- new commercial presentation
- cancellation of registration of drug product presentation
- new drug product shelf life
- extension of shelf life for the drug substance/ for the drug product
- updating of specifications and analytical method of active ingredient, bulk product, finished product, adjuvant and stabilizers not included in official compendium
- inclusion of manufacturing site of the drug product in its primary/ secondary packaging
- deletion of the manufacturing site of the bulk drug product
- deletion of the manufacturing site of the drug substance
- inclusion of primary packaging
- labeling text change
- database correction request
- official Gazette publishing correction request
Low complexity PAV filings are defined like those ones that do not need ANVISA prior approval. Mid complexity filings are properly defined in applicable regulation. In case of doubt the regulation has to be consulted.
Collaborate with the Regulatory Affairs team members to feed in a timely basis BMS databases to maintain regulatory records fully accurate and updated (PRISM/ CARA, Verity, SharePoints, PSUR reports, etc). Collaborate with the Regulatory Affairs team members to create a local labeling in full adherence to target labeling strategy. Collaborate with the Regulatory Affairs team members to timely updating local labeling in full adherence to CCDS, BMS policies, local target labeling strategy and local regulations.* Collaborate with the Regulatory Affairs team members to create and update local packaging components.* Support to update procedures, manuals and work instructions of the area. Collaborate with the Regulatory Affairs team members to Provide regulatory information as requested by partner areas (i.e. SAC, bids, logistics, importation, etc.)*
- For these tasks a GRS Manager is accountable.
**EXTERNAL FOCUS**
- Support the Regulatory Affairs team members to drive contacts and consultations with HA within his/her scope*.
- Collaborate with the Regulatory Affairs team members in Continuously monitoring key competitors identified by marketing team.
Collaborate with the Regulatory Affairs team members to prepare the assessment of new regulation and public consultations versus business impact (PEARL).
- For these tasks a GRS Manager is accountable.
**CONNECTIVITY**
- Focus on patient and customer needs to drive results.
- Connects and collaborates across the local, regional and global functions as required.
- Builds personal credibility and strong working relationships.
- Learns and shares best practices across the function.
- Demonstrates commitment to timely deliver quality results.
**Key Outputs and measurements**
Develops its own working plan taking accountability for ti

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