Senior Regulatory Associate

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. Provide informed, accurate regulatory guidance, and strategic input, to BMS development programs to assure prompt, successful approval of applications by Health Authorities. Develop and implement regulatory strategies by pre-empting potential problems in regulatory packages and taking effective steps to deal with them. Work well within the regulatory system and find ways to overcome obstacles. Drive regulatory process to ensure appropriate and timely filing and approval of new products (NCE’s, line extensions), product variations (inclusive of changes in CMC, labelling), plant registration, PIC/S GMP compliance and renewals, in accordance with business objectives. Decide and act in a timely manner. Maintain a strong sense of urgency to a high level of quality, focusing on the ultimate business objectives. Communicate and escalate promptly, where required. Connect and collaborate with key stakeholders (Health Authorities, customers and business colleagues within BMS). Establish strong working relationships. Actively solicit necessary input from stakeholders to achieve registration objectives, time lines and business goals. Co-operate with and support Global Supply Chain as required. Anticipate and identify trends and changes in regulatory attitudes and requirements that may impact on the business. Communicate these effectively to all the stakeholders. Grow self & peers by sharing regulatory experiences and promoting best practices. Support team members in managing business and regulatory requirements. Manage self and the complexity of multiple, competing priorities (time, expenditure) to meet agreed goals. Engage necessary people, resources to manage conflict of priorities. Manage functional and organizational projects to completion, as required by business needs. Engage necessary people, resources to manage conflict of priorities. Deliver effective presentations to local, regional and global colleagues and Health Authorities as appropriate. 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.