GRS Associate Director Brazil

GRS Associate Director Brazil (Regulatory Affairs) Join to apply for the GRS Associate Director Brazil (Regulatory Affairs) role at Bristol Myers Squibb . 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 at 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 market. 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. Key Responsibilities Accountable for operations strategically aligned to BMS goals and behavior's Establish local infrastructure and ensure regulatory compliance with national competent authority legislation for marketing and distribution of products Lead the successful launch of new product development by ensuring 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 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 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 Benefits Bristol Myers Squibb offers a wide variety of competitive benefits, services and programs to support your career and well‑being. EEO & Disability 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. Additional Information If you live in or expect to work from Los Angeles County, please visit this page for important additional information: Combining the best of academic and translational science, the Regulatory Affairs Associate Director will support products across all BMS therapeutic areas. Seniority Level Director Employment Type Full‑time Job Function Legal Industries Pharmaceutical Manufacturing #J-18808-Ljbffr