GRS Associate Director Brazil (Regulatory Affairs)

Bristol Myers Squibb; São Paulo; Presencial; BRL 200.000 - 250.000; Tempo integral

Resumo da oferta

Uma empresa farmacêutica líder em São Paulo procura um Associado Diretor de Assuntos Regulatórios com experiência para liderar a estratégia regulatória no Brasil. O candidato ideal deve ter um mestrado em farmácia ou ciências químicas, 5 anos de experiência em CTA/NDA e fluência em português e inglês. Essa função é essencial para garantir o sucesso de novos lançamentos de produtos e a conformidade regulatória com as autoridades locais.

Serviços

Benefícios competitivos

Flexibilidade no ambiente de trabalho

Cultura de inclusão e diversidade

Qualificações

• Mais de 5 anos de experiência em CTA/NDA no Brasil.
• Bom entendimento da infraestrutura regulatória de produtos farmacêuticos.
• Capacidade de apresentar estratégias regulatórias complexas de forma independente.

Responsabilidades

• Responsável pela estratégia regulatória do mercado.
• Garantir a conformidade regulatória com as leis nacionais.
• Liderar o lançamento de novos produtos e mudanças pós-aprovação.

Conhecimentos

Fluência em português

Fluência em inglês

Comunicação profissional

Planejamento e organização

Capacidade de escrita técnica

Formação académica

Mestrado ou superior em farmácia ou ciências químicas

Descrição da oferta de emprego

Overview

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. 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 Summary

Reporting to the LATAM/Brazil Regulatory Director, as Regulatory Affairs Associate Director, this position will lead the establishment of Regulatory Affairs management in the Brazil.

Responsible for all aspects of the market Regulatory Strategy, you will support the growth of the pipeline and build consistent strategies to support earlier launches. In this role you will work closely with the Global Regulatory Lead, Regulatory Product Leads, Scientific Areas and General Manager in cross-functional project teams, to ensure innovation and new launches are achieved.

Our Regulatory Affairs Department is focused on continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment with the ability to support and shape the external environment.

Responsibilities

• Accountable for operations strategically aligned to BMS goals and behavior’s
• Establish local infrastructure and ensure regulatory compliance with the national competent authority legislation for the marketing and distribution of products
• Lead the successful launch of new product development by ensuring the timely roll out of new applications and post approval changes.
• Country regulatory lead representing due diligence assessments and development opportunities.
• Ensure planning and optimal organization of country and global regulatory activities.
• Drive growth opportunities in Brazil through strategic planning and in depth understanding of the regulatory framework.
• Ensure full readiness and compliance of the local entity and all related activities for products commercialization.
• Lead interactions and submissions with the ANVISA and related Health Authorities
• Monitor, identify and communicate regulatory environmental trends and regulation development which would influence BMS growth opportunities.
• Active member of local associations

Qualifications & Experience

• Master’s degree or above in pharmacy, or chemical sciences
• Proven record and at least 5 years of experience of CTA/NDA and associated strategy in Brazil
• Good understanding of the regulatory infrastructure required for the marketing and distribution of pharmaceutical products.
• Strong knowledge of local regulatory framework and guidelines
• Must be able to independently present complex global regulatory strategies internally and externally.
• Expertise in writing scientific and technical documents.
• Overall global expertise, professional gravitas and strong influence skills and will display personal and professional maturity.
• Data driven in decision making with the ability to analyze complex situations, focus on the key issues and communicate within the team and upwards with clarity and concisely.
• Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
• Strong networking, planning and organizational skills with a demonstrated capability to manage complex projects with short timelines and work successfully within cross-functional teams.
• Excellent professional communication skills, both written and verbal
• Fluency in both Portuguese and English languages required.

Additional Information

If 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 a supportive culture, promoting global participation 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 an 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 [e-mail]. 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.

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: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.