Regulatory Manager

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. 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 local/global GRS, local management, marketing and medical teams. Grow self & peers by sharing regulatory experiences and promoting best practices. Support team members and GRS (Associate) Director 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. Mentor other staff, as required by business needs. Embed BMS Biopharma behaviours in teams. Deliver effective presentations to local, regional and global colleagues and Health Authorities as appropriate. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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.