Location: Budapest, Pest, Hungary
Category: Regulatory Affairs
Job ID: 202411-129477
At Roche, we believe that diversity, equity, and inclusion are key ingredients to our success. As a Regulatory Specialist, you will play a vital role in compiling documents and supporting product registration timelines for diagnostics products. You will maintain clear communication with internal stakeholders and external partners, including health authorities, to ensure compliance with regulatory requirements throughout a product’s lifecycle.
Product Registration Support:
Assist with the preparation and compilation of documentation for product registrations, ensuring compliance with regulatory requirements. This includes providing support for currently marketed products, addressing labeling, product, and manufacturing changes, and ensuring appropriate approvals.
Regulatory Compliance:
Maintain product registration and ensure compliance with relevant regulations throughout a product’s lifecycle. Apply regulatory change control processes and stay aligned with global regulatory directives and regulations.
Documentation Management:
Compile and maintain regulatory documents in the Regulatory Information Management System (RIMS). This includes creating and updating product information, preparing reports, and maintaining technical files.
Collaboration with Internal Stakeholders:
Work closely with other functions to collect data and prepare necessary documentation. Engage in discussions around product registration strategies and regulatory submissions.
International Regulatory Submissions:
Support international regulatory submissions by providing required data, responding to health authority queries, and ensuring affiliates are informed of new products, projects, or process changes.
Regulatory Reporting:
Support annual reporting and other required regulatory reports in relevant countries, ensuring all deadlines are met for documentation submission.
Educational Background:
A university degree or equivalent qualification in a related field, with a focus on regulatory affairs, life sciences, or a relevant area.
Experience:
At least 2-3 years of experience in regulatory affairs within the diagnostics or pharmaceutical industry. Knowledge of regulatory processes for medical devices, IVDs, and diagnostics products is highly preferred.
Skills & Competencies:
Language Skills:
Proficiency in English is required, both spoken and written. Knowledge of other languages is a plus.
If you are ready to take on this exciting challenge and help us drive regulatory excellence at Roche, we encourage you to apply. Please submit your CV and any other relevant documentation.
At Roche, we are committed to fostering an inclusive and diverse environment. We strive to create a workplace where every voice matters and where individuals can contribute to making a difference in the healthcare industry. If you are passionate about regulatory affairs and want to be part of an organization that puts patients at the center of everything we do, apply today.
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Ahmedabad | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Remote - Europe | Remote - Middle East | Switzerland | Remote | Remote - South America (Latin Americal) | Remote, USA | Remote - Africa |Bucharest :
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Khulais | Rabigh | Najran | King Abdullah Economic City | Riyadh | Jeddah |Nišava District :
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