Analista de Assuntos Regulatórios Pleno

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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.

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 Full Analyst should be prepared to work in this environment and deliver the expected results through teamwork, timely and quality under certain supervision.

The position is in full compliance with BMS laws, regulations, policies and procedures, including business rules, as well as BMS Conduct and Ethics.

**Travel required**:Yes

**Direct reports**:No

**Objectives/ responsibilities include, but are not limited to**:
**SPEED TO PATIENT**

**Understands and fulfills current and local regulations and internal policies while assessing, planning and executing regulatory processes**: planning, preparing, submitting and tracking thru approval non-asset specific regulatory processes required for the continuity of BMS operations in Brazil, including (but not limited to) GMP certificates, operating authorization and working license maintenance, and Pharmaceutical Council Documentation. timely delivering pre-filing requirements (DCBs, new GMP certificates, cold chain validation, analytical transfer, dissolution profile, among others). preparing registration renewal, HMP and regulatory low-mid complexity filings without major 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.

assisting on preparation of major filings under certain supervision, like BLA, NDA, LCM and DDCM, according to pipeline submission plans tightly aligned with the endorsed strategy and targeted timelines.*

Major complexity filings are defined like those ones that need ANVISA prior approval. In case of doubt the regulation has to be consulted.

preparing comprehensive and timely responses to HA queries.* providing ToC (table of contents) related to registration and PAV (post approval variations) to Global GRS teams. providing SME support for product divestitures or deletions and secure proper regulatory actions required as result of the decision.* preparing and submitting extemporaneous mandatory notifications (i.e. OOS, shortages, quality deviations, recalls, etc.) and following up on derived actions until completion*. feeding in a timely basis BMS databases to maintain regulatory records fully accurate and updated (PRISM/CARA, Verity, SharePoints, PSUR reports, etc.) creating local labeling in full adherence to target labeling strategy t