Grs Associate Director Brazil

Working with UsChallenging.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.Position SummaryReporting to the LATAM/Brazil Regulatory Director, as Regulatory Affairs Associate Director, this position will lead the establishment of Regulatory Affairs management in the BrazilResponsible 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 Areass and General Manager in cross-functional project teams, to ensure innovation and new launches are achieved.Our Regulatory Affairs Department is focused 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.Key Responsibilities Accountable for operations strategically aligned to BMS goals and behavior'sEstablish local infrastructure and ensure regulatory compliance with the national competent authority legislation for the marketing and distribution of productsLead the successful launch of new product development by ensuring the timely roll out of new applications and post approval changes.Establish regulatory strategies and develop submissions for CTAs, NDA submission, NMC meetings, life-cycle management and labelling management.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 México 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 AuthoritiesMonitor, identify and communicate regulatory environmental trends and regulation development which would influence BMS growth opportunities.Active member of local associationsQualifications & ExperienceMaster's degree or above in pharmacy, or chemical sciencesGreat IT skills including MS Word, Excel, Project, PowerPoint, and OutlookProven record and at least 5 years of experience of CTA/NDA and associated strategy in MéxicoProven experience in submitting biologics NDAs and accurate understanding of the requirements including patent request.Good understanding of the regulatory infrastructure required for the marketing and distribution of pharmaceutical products.Strong knowledge of local regulatory framework and guidelinesMust 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.Ability to work successfully within cross-functional teams.Excellent professional communication skills, both written and verbalFluency in both Spanish and English languages required.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as "Transforming patients' lives through scienceTM ", 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 ProtocolBMS 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 .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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.