Analista de Assuntos Regulatórios Sênior – Bristol-Myers Squibb

Titulo da Vaga: Analista de Assuntos Regulatórios Sênior

Localização: São Paulo – SP

Descrição da Vaga: 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.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: .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 company’s growth, enabling the expansion and renewal of its portfolio through regulatory processes with ANVISA. This environment is constantly changing, requiring companies to anticipate changes, analyze impacts, and implement plans effectively. Additionally, Regulatory Affairs ensures compliance with health regulations to continue business operations, avoid penalties, and protect the company’s image.
The Regulatory Affairs Senior Analyst must work independently, delivering results through teamwork, timeliness, and quality.
This position must comply with BMS laws, regulations, policies, procedures, and the BMS Conduct and Ethics.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: – a) Prepare major filings (BLA, NDA, LCM, DDCM) without supervision, aligned with pipeline submission plans and targeted timelines.*b) Prepare comprehensive and timely responses to Health Authority (HA) queries.*c) Provide Table of Contents (ToC) for registration and post-approval variations (PAV) to Global GRS teams.d) Provide SME (subject matter expert) support for product divestitures or deletions and secure proper regulatory actions required as result of the decision*.e) Prepare and submit mandatory notifications (e.g., OOS, shortages, quality deviations, recalls) and follow up on actions until completion*.f) Maintain accurate and updated regulatory records in BMS databases (CARA, Verity, SharePoints, Activities Control).g) Create and update local labeling and packaging components in adherence to target labeling strategy, CCDS, BMS policies, and local regulations.h) Review and approve promotional materials.i) Update procedures, manuals, and work instructions for the area.j) Provide regulatory assessment during investigations of unforeseen issues, with GRS Managers leading the investigation and formulating mitigation plans*. For regulatory-originated issues, GRS Managers lead the investigation, develop mitigation and contingency plans, identify impacted areas and processes, and ensure resolution to prevent business disruption and avoid harm to patients.k) Provide regulatory information as requested by partner areas (e.g., SAC, logistics, importation)*.*For these tasks a GRS Manager is accountable.EXTERNAL FOCUSa) Drives contacts and consultations with HA within his/her scope*.b) Supports the preparation and deployment of HA interactions, including slide kit, documentation, rehearsal meetings among others.*c) Participates of F2F meetings or other interactions with HA when designated.*d) Monitor and analyze the regulatory environment and key competitors, sharing relevant insights.

• Continuously monitoring key competitors identified by marketing team.
• Collect and analyze benchmarking data to propose reference timelines for regulatory plans*.

e) Participates in Trade Association meetings, work streams, subject specific groups or taskforce groups when designated.f) 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
• Demonstrate commitment to delivering quality results in a timely manner.

Key Outputs and measurementsDevelop and take accountability for own working plan, ensuring timely completion of assigned functions.Ensure timely delivery of quality results with a sense of urgency and priority.Align key outputs with company objectives. Measurement occurs during 1:1 meetings, coaching sessions, and performance appraisals.Key Contacts/ StakeholdersInternal

• GRS team
• Local regulatory team
• Intercon Regulatory Lead (IRL)
• 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 / LanguageEducation

• Bachelor’s 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.

Language

• Fluent in Portuguese and English written/oral

#LI-hybridIf you come across a role that intrigues you but doesn’t 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 ProtocolBMS 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 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.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Nome da Empresa: Bristol-Myers Squibb

Salário:

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