Regulatory Affairs Manager

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. Rattaché au Directeur Associé Affaires Réglementaires en Oncologie, vous réaliserez les activités liées aux missions du département Affaires Réglementaires en France, dans le respect des dispositions du Code de la Santé Publique, des lois françaises et internationales, de la Charte de l’information promotionnelle et des procédures internes en vigueur. Responsibilities La publicitéet les supports non promotionnels ; vous vérifierez et approuverez les documents promotionnels, les documents non promotionnels et les supports de formation de la visite médicale en conformité avec la réglementation et vous vous assurerez du dépôt des dossiers de demande de visa publicité dans les délais requis. Notamment dans le cadre de lancement de produits et nouvelles indications. La pharmacovigilance et la gestion des risques; vous préparerez et mettrez à jour les outils de minimisation des risques des produits dont vous aurez la charge. Vous collaborerez notamment avec les équipes de Pharmacovigilance Internes ces produits. Vous serez également impliqué dans le suivi del’enregistrement des produits, en collaboration avec les équipes internationales, la validation des articles de conditionnement et les constitutions des dossiers de transparence. Selon le développement du médicament, vous serez impliqué dans la mise en œuvre d’accès dérogatoires Vous serez amené à contribuer à desprojets transverses au sein du département. Vous fournirez un support et des conseils aux équipes concernées (marketing, médical, qualité, ventes et formations) sur les aspects réglementaires Vous participerez à la rédactions et révisions des procédures inhérentes aux activités règlementaires Vous assurerez un support réglementaire auprès de la Direction Internationale des Affaires Réglementaires pour l’autorisation et le suivi des essais cliniques mise en œuvre par BMS ou en collaboration avec des promoteurs institutionnels. Profil et compétences recherchés : Pharmacien, spécialisation en Affaires Réglementaires Au moins 3 ans d’expérience réussie en Affaires Réglementaires, de préférence au sein de laboratoires de produits innovants. Esprit d’équipe et aisance à travailler en équipe Esprit positif et constructif Capacités d’adaptation Capacité d’analyse des risques et force de proposition Très bonne maitrise de l’anglais (oral et écrit) Maîtrise des outils bureautiques (pack Microsoft Office) Des compétences en Intelligence Artificielle serait un atout 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 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. Supporting People with Disabilities 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 adastaffingsupport@bms.com. Visit careers.bms.com/eoe-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights 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/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. #J-18808-Ljbffr