Roche

Regulatory Affairs Assistant

Roche  •  Belgrade, RS (Onsite)  •  2 hours ago
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Job Description

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

Should you answer the above challenges and requirements with YES then this is the right position for you!

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.

Roche is an Equal Opportunity Employer.

Roche

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).

For more information, please visit https://careers.roche.com

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Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
Switzerland 🇨🇭 , CH
Year Founded
Unknown
Website
roche.com
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