Student Assistant Regulatory Affairs

Bavarian Nordic A/S; Kvistgård; On-site; DKK 165,000 - 220,000; Part time

Job summary

Bavarian Nordic A/S is seeking a part-time Student Assistant for the Regulatory CMC team in Kvistgård. You will support regulatory information management tasks and help ensure metadata quality in Veeva RIM.

The role emphasizes accuracy, collaboration with international colleagues, and learning how regulatory submissions are prepared. You will balance study commitments with about 15 hours per week and gain insight into a regulated biotech environment.

Qualifications

• Currently studying pharmaceutical sciences or biotechnology.
• Detail-oriented with a focus on quality and compliance.
• Collaborative team player with a proactive approach.
• Good command of English (speaking, reading, writing).

Responsibilities

• Maintain and improve regulatory information management data in Veeva RIM.
• Align information to current naming conventions and Ways of Working.
• Collaborate with Regulatory CMC and Regulatory Operations teams.
• Support administrative tasks related to submissions and learn about the regulated environment.

Skills

Attention to detail

Proactive attitude

Collaborative mindset

English proficiency

Education

Pharmaceutical sciences / Biotechnology (student)

Tools

Veeva RIM

Job description

Would you like to get some hands-on experience in a regulatory department? Are you motivated by working for a company with a strong purpose? Great! Because we are looking for a Student Assistant to support our regulatory department with regulatory information management tasks.

Boost our team

You will join our global regulatory CMC team of 12 dedicated employees. You will report to the Head of Regulatory CMC in the regulatory department, located in our offices in Kvistgaard. In Bavarian Nordic you will join a small but global and professional organization where you will get to work with international colleagues.

Your tasks will include

• One part of our work is related to regulatory information management. Our documentation and metadata in this regard are recorded in the Veeva RIM system. The task is to ensure that old records can be retrieved by improving the connected metadata to current level.
• The task also includes alignment of information to match current naming conventions and Ways of Working.
• The successful transformation of metadata requires that you work closely with the Regulatory CMC team and our Regulatory Operations Team.
• In addition, you will be expected to support other administrative tasks related to our submissions. You will get a sneak peak to our regulated environment and how we interact with agencies.
  

We expect you to work approximately 15 hours a week with flexibility around exam periods.

Who are you?

The ideal candidate is currently studying pharmaceutical sciences/biotechnology and have a flair for quality and compliance. We are seeking a proactive, detail-oriented student with a passion for doing thinks correctly and have a collaborative mindset. As the role involves close cooperation with international colleagues, it is essential that you are able to speak, read, and write in English. Your dedication, adaptability, and willingness to learn within a dynamic regulatory environment will be vital in this role.

Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.

Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

For more information, visit www.bavarian-nordic.com

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Location:

Kvistgaard - Hejreskovvej 18