Senior Regulatory Manager

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.

Position Summary

Responsible for all regulatory activities related to assigned products (centrally registered and under development) including the local support of clinical trial applications in the role as Regulatory Manager. Ensuring of compliance with local regulatory requirements. Regular interactions with local Regulatory Authorities. Management of internal (global and local) databases.

Position Responsibilities

·       Responsible for assuring that approved labelling is implemented in production in accordance with local legislation.

·       Responsible for regulatory translations for CZ.

·       Responsible for local support of clinical trial applications in line with EU Clinical Trial Regulation.

·       Responsible for interactions with Country Regulatory Authority in CZ and feedback to BMS regarding product registrations and clinical trial applications.

·       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 Associations.

·       Responsible for the review and approval of Advertising & Promotional materials of assigned products in CZ.

·       Contribute to the relevant stakeholders with Regulatory Intelligence for CZ.

·       Supports creation and maintenance of local procedural documents.

·       Support reimbursement processes to ensure timely negotiations and approvals in accordance with business objectives.

Degree Requirements

·    University degree (Bc / Mgr) in Life Science area

Experience Requirements

·    Minimum 3 years of experience in Regulatory Affairs

Key Competency Requirements

·    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 Czech and fluent English (oral and written)

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 excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to