Vaga de Sr. Regulatory Affairs Analyst / Analista de Assuntos Regulatorios Sr

Working with Us Challenging. Meaningful. Life-changing. Those arent 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. Youll 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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. 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 Senior Analyst should be prepared to work in this environment without any supervision and deliver the expected results through teamwork, timely and quality. 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, as well as the extent of impact of evolving changes, while assessing, planning and executing regulatory processes: preparation of major filings without 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 (subject matter expert) 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, Activities Control, PSUR reports, etc.). creating local labeling in full adherence to target labeling strategy. timely updating local labeling in full adherence to CCDS, BMS policies, local target labeling strategy and local regulations*. creating and updating local packaging components*. reviewing and approving promotional materials*. updating procedures, manuals and work instructions of the area. being technical support to the Regulatory Affairs Assistant. providing regulatory assessment during investigations of raising unforeseen issues*. For issues originated in/by regulatory, GRS Managers lead the investigation, formulate mitigation/ contingence plans, identify impacted areas and processes until closure of the even, in order to prevent business disruption and avoid damage to patients. providing regulatory information as requested by partner areas (i.e. SAC, bids, logistics, importation, etc.)* *For these tasks a GRS Manager is accountable. EXTERNAL FOCUS Drives contacts and consultations with HA within his/her scope*. Supports preparation and deployment of HA interactions: slide kit preparation, documentation preparation, rehearsal meetings among others. Participates of F2F meetings or other interactions with HA when designated. Searches, monitors, collects, discerns, share and applies relevant information and insights about regulatory environment and key competitors. Continuously monitoring key competitors identified by marketing team. Monitors, collects and analyses benchmarking data to propose reference timelines for regulatory plans*. Participates in Trade Association meetings, work streams, subject specific groups or taskforce groups when designated. Leads/ participates of 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 timely completion of assigned functions. Takes full accountability for timely delivery of quality results, with reasonable sense of urgency and priority. The key outputs must be aligned with the objectives of the company. Your measurement takes place during 1:1, coaching sections and your company's performance appraisals. Key Contacts/ Stakeholders Internal GRSB team Local regulatory team International Strategic Liaisons (ISL) Global Labeling Operations CMC Managers Global Document Managers Local QCQA Supply Chain (Demanding Planner, Replenishment Planner) Packaging coordinators and marketing services External ANVISA COVISA VISA Itapevi Trade Associations (Interfarma and Sindusfarma) Divestiture partners Skills, Competencies and Knowledge Knowledge of the regulations applicable to new and biological drugs Teamwork, interpersonal relationships, commitment and dynamism Ability to communicate fluently (written and verbally) in English and Portuguese Ability to organize / prioritize tasks Negotiation skills and cross-functional working experience Commitment to timely deliver quality results Knowledge on Office package Education / Experience / Language Education Bachelors degree in Pharmacy is required. Experience Experience in the regulatory area in the various types of regulatory processes: preparation of new product registration, post registration, renewal, maintenance of records and administrative documents (GMP certificate, Licenses, etc.), regulatory intelligence and policies as well as other routine regulatory activities. Previous experience with biological drug is mandatory. Language Fluent in Portuguese and English written/oral #LI-hybrid If you come across a role that intrigues you but doesnt perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients lives through science" , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.