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.
BMS is hiring a **Regu** **latory Manager** in Budapest who will be responsible for all regulatory activities related to assigned products.
· Responsible for assuring that approved labelling (SPC, PL, pack) is implemented in production in accordance with local legislation.
· Responsible for Regulatory translations for Hungary.
· Responsible for filing clinical trial applications to the competent regulatory authorities in Hungary, and all following interactions, in line with BMS company policies and practices, the European Clinical Trial Directive and local legislation.
· Responsible for interactions with Country Regulatory Authority in Hungary and feedback to BMS regarding product registrations.
· Drives and support local projects and department related assignments.
· Responsible to keep up to date with the regulatory environment within the industry.
· Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases.
· Act as a key partner with the country Business function, Medical function, Clinical Operations function, Market Access function and Quality/Distribution function.
· Develop the necessary external contacts with e.g. Regulatory Agency, Trade Association.
· Responsible for the review and approval of Advertising & Promotional materials in Hungary as per the approved SmPC, the Ethical Rules issued by local authorities and BMS´s procedural documents.
· Contribute to the relevant stakeholders with Regulatory Intelligence for Hungary.
· Creates and updates local procedural documents.
· Support reimbursement processes to ensure timely negotiations and approvals in accordance with business objectives.
· Responsible for development and maintenance of the Hungarian Regulatory QMS.
+ University degree (Bc / Mgr) in Life Science areaplus minimum 5 years of relevant experience in pharmaceutical industry/regulatory affairs
+ Minimum 3 years of experience in regulatory affairs
+ Demonstrated ability in planning, problem solving, internal and external negotiations and time management
+ Demonstrated ability to manage regulatory processes
+ Knowledge of the EU and local legislation and local pharmaceutical industry.Native Hungarian and good English (oral and written)
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.
**Company:** Bristol Myers Squibb
**Req Number:** R1529852-en-us
**Updated:** 2020-10-20 01:42:10.253 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.