Regulatory Science Manager in Bucuresti

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. As a Regulatory Science Manager you will be accountable for the Regulatory activities within BMS portfolio (includes but not limited to orphan drugs, biologics, oncology therapeutics and advanced therapies) in line with the local, regional and global strategies and in accordance with local regulations, codes of conduct and standard operating procedures (SOPs) Main Responsibilities: Manage the review, preparation, submission and follow-up of regulatory submissions to ensure that marketing authorizations are maintained in line with the company’s plans and goals. Ensure the labeling text and packaging components are in compliance with local registered details and corporate prescribing information performance Support CTA regulatory activities Support the development of promotional materials Provides input for brand team strategies in line with development plan and commercial priorities for own portfolio Build relationships with key external stakeholders, in order to communicate BMS policies and strategies and negotiate outcomes. Manage compliance within defined portfolio/activity streams in line with company’s expectations Collaborative working together with other functions (e.g., marketing, supply chain, quality). Maintain required regulatory compliance databases, systems and processes. Maintain high level of knowledge on the science of products within defined portfolio Perform regular interactions with local Regulatory Authorities regarding product registration, clinical trial applications, supply, compliance and safety for Romania Analyze regulatory issues and communicate effectively with key stakeholders, including global colleagues. Work together to help develop plans to mitigate, so that we can deliver products backed by science that are robust and aligned with business needs. Proactively identify potential regulatory risks within defined scope of responsibility on the business. Desired competence and experience: To succeed at BMS you need integrity, innovation, urgency, passion, accountability and inclusion. As Regulatory Science Manager you need: At least 3-5 years of regulatory experience in the pharmaceutical industry. Additional experience in Operational roles / related fields will be considered as advantage. Bachelor Degree in life sciences. Master/PhD will be considered an asset Strong understanding of the Local and EU regulatory environment/ Legislation. Established contacts within the regulatory bodies. Thorough understanding of the international aspects of RA processes, health authorities (EMA), local/ National Health Authorities’ regulations Ability to handle various IT systems and databases Good organizational skills and ability to manage multiple projects/priorities and cope with tight deadlines. Act with a sense of urgency Goal-oriented attitude with high sense of accountability “Proactive, Solution finding” mind set with the Ability to foresee and respond to potential problems and opportunities. Self-motivated with strong verbal and written communication skills. Able to communicate effectively and efficiently with other functional departments in the business. An in-depth working knowledge of licensing processes for marketing authorizations via national, mutual recognition, decentralized and centralized procedures, and submission to regulatory authorities. Fluency in English and Romanian, both in verbal and written communication What BMS can offer you At BMS, we support our employees to reach their full potential by learning and growing every day. Employees have the opportunity to take on new challenges within their current role or leading or participating in different company initiatives. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to gender identity, race, colour, religion, sexual orientation, national origin or disability. 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.