Senior Manager Global Regulatory Science - Netherlands

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: careers.bms.com/working-with-us. Reporting to the Lead GRS The Netherlands, manages the daily regulatory activities in The Netherlands acquiring and increasing a working knowledge and understanding of BMS products and regulatory processes. Manage regulatory processes in line with business/R&D objectives to ensure timely registration of new products/line extensions and variation applications of BMS products. Liaise with the Regulatory Agencies in The Netherlands for assigned products. Responsible for assuring that approved labelling (SmPC, PL, pack) is implemented in production in accordance with local legislation and BMS procedures Monitor and lead the implementation of solutions to changes in legislation and Heath Authority processes. Work with local Medical, Marketing, Market Access, Quality and Global Labeling to ensure that regulatory aspects of labeling comply with local legislation and BMS requirements. Provide strategic input into product labeling texts (SmPC/PIL) and qualitative review of labelling materials in local language(s), ensuring compliant implementation. Responsible for regulatory translations for Benelux and coordination of translations in country (as applicable). Oversee the submission of variation applications and approvals for nationally approved products in The Netherlands. Responsible for Drug Safety related GRS tasks as per Drug Safety BMS procedures (DHPC, aRMA) and in collaboration with local Drug Safety. Responsible for filing clinical trial applications to the competent regulatory authorities in The Netherlands, and all following interactions, in line with BMS company policies and practices, the European Clinical Trial Directive (and subsequent CTR) and local legislation. Support the approval process of Early Access Programs (Compassionate use/Medical need programs) and having thorough understanding of required EAP legislation and processes Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases. Support local projects, regulatory and department related assignments. Act as the key GRS partner for the assigned therapeutic area with the country Business functions, Medical function, Clinical Operations function, Market Access function and Quality function. Support launch activities and provide key pre-launch support. Responsible for the review and approval of Advertising & Promotional materials in The Netherlands as per the local legislative framework and Ethical Code, and BMS´s procedural documents. Support reimbursement processes to ensure timely negotiations and approvals in accordance with business objectives. Support development and maintenance of the Benelux Regulatory QMS. Create and update local procedural documents. Keep up to date with the regulatory environment within the industry. Develop the necessary external contacts with e.g. Health Authorities, Regulatory Agencies and building a key network with Trade Associations. Establishes and maintains co-operative working relationships with peers and co-workers. Contribute to a high performing organisation and culture by developing and performing in a strong regulatory team. Continues to upgrade experience by participating in BMS sponsored training to develop technical skills, communication effectiveness and leadership potential. ry. 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 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 Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. 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.