Regulatory Affairs Assistant
Roche
BelgradePosted about 16 hours agoDiscoveredMatch locked
Full time
About the role
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
Regulatory Affairs Assistant
At Roche, we believe it is critical to deliver medical solutions now - even as we develop innovations for the future. We are passionate about transforming patients' lives and we are fearless in both decision and action. And we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
Purpose
As a Regulatory Affairs Assistant at Roche you will play a crucial role in supporting the Regulatory Affairs team in ensuring compliance with regulations and guidelines set by regulatory authorities. This role plays a significant part in helping Roche navigate a complex regulatory landscape and ensure that products meet all necessary regulatory standards.
Responsibilities
- You will provide operational and administrative support to the Regulatory Team
- You will get acquainted with Medical Devices, Law of Medical Devices and registered portfolio
- You will update all Regulatory Records and systems
- You will collect relevant registration request documentation and submit Requests in ALIMS application
- You will process and communicate Regulatory Team notifications on newly issued MAs to stakeholders
- You will process tender participation/customs Authorization requirements
Requirements & Qualifications
- You are graduate of the Faculty of Pharmacy (preferred Master of Pharmacy - Medical Biochemist)
- You have advanced knowledge of MC Office package
- You have good knowledge of the English language
- You are precise, accurate and you have a thorough approach to tasks and responsibilities
- You are ready to be fully committed during the working week
- You are ready to learn and collaborate with the team
- You have good communication skills and high level of self-organization
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
Who we are
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
Not included in the source posting: benefits.
Who can apply
The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.
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