Job Description: Regulatory Specialist
Location: Budapest, Hungary
Contract Type: Full-Time, Permanent
About Roche
Roche is a global leader in healthcare, dedicated to pushing the boundaries of science to improve the lives of patients. We foster a culture of innovation, collaboration, and inclusivity. At Roche, we value diversity and believe that every individual’s unique perspective helps us meet the varied healthcare needs of people worldwide.
The Position
As a Regulatory Specialist at Roche, you will play a critical role in the successful management and submission of regulatory documents, ensuring compliance throughout the product lifecycle. You will collaborate with internal teams and external partners, including health authorities, to facilitate regulatory approvals, providing vital support to marketed products and driving product registration strategies.
Key Responsibilities
Support Regulatory Compliance:
Ensure timely submission of regulatory documentation and maintain product registration through its lifecycle.
Monitor and maintain compliance for marketed products, including product and manufacturing changes, labeling, and reporting for regulatory agency approval.
Handle regulatory changes and ensure that product registration stays up-to-date.
Documentation Management:
Collect and organize data from various stakeholders to prepare and maintain regulatory documentation, including technical files and compliance reports.
Manage the Regulatory Information Management System (RIMS) and ensure it reflects accurate product information.
Prepare and maintain reports and documents related to regulatory activities and submission processes.
Collaborate Across Functions:
Work closely with internal teams and external partners to gather the necessary data and documents for regulatory submissions.
Support the preparation of documentation for international regulatory submissions and communicate with Health Authorities to address queries.
Assist with submission activities, including PMA supplements, 510(k) submissions, and 30-day notices.
Regulatory Reporting and Tracking:
Participate in reporting, including annual and laser reporting as required by relevant countries.
Ensure accurate tracking of compliance-related activities to meet Global Regulatory requirements.
Who You Are
Educational Background and Experience:
Bachelor’s or Master’s degree (or equivalent experience) in Regulatory Affairs, R&D, Quality, Operations, or Clinical disciplines.
0-5 years of relevant experience in Regulatory Affairs or related fields such as R&D or Quality Management.
Equivalent experience may also be considered, including completion of technician training or laboratory technician qualifications.
Skills and Competencies:
Strong attention to detail and the ability to work autonomously.
Excellent organizational and time-management skills, with the capacity to manage multiple tasks efficiently.
Fluent in English; proficiency in German is a plus.
Why Join Roche?
Development Opportunities:
Roche offers continuous learning and development programs, free language courses, and the opportunity for internal career mobility and international assignments.
Competitive Benefits & Flexibility:
Enjoy a competitive salary, cafeteria package, annual bonus, private medical services, and employee assistance programs.
Take advantage of flexible working practices, including the option for home office (2 office days per week) and full remote working within Hungary.
Inclusive Culture:
Join a global and diverse community where you will learn from others, share knowledge, and contribute to Roche’s mission of making a difference in healthcare.
Roche promotes a supportive leadership culture focused on people, ensuring you have a voice in the organization.
Roche is an Equal Opportunity Employer
We believe in diversity and inclusion, and we are committed to ensuring that every employee has an opportunity to thrive in a collaborative and innovative environment.
For more information on how we handle your personal data during the recruitment process, please read our Data Privacy Notice.
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Japan | Saitama |Tokyo :
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