Regulatory Compliance Assistant, Global Regulatory Affairs

Job title: Regulatory Compliance Assistant, Global Regulatory Affairs

Company: ALK-Abelló


Job description: Are you curious and comfortable using digital tools? Are you interested in the pharmaceutical industry working with IT systems and regulatory affairs? Are you in between studies and looking for an opportunity to gain industry experience in your gap year?A dynamic and skilled Regulatory Compliance and Operations team with 8 colleagues is looking for a new assistant to join on a temporary contract. Join us and gain valuable experience in a global, digital, and highly collaborative environment.The position
You will be part of Global Regulatory Affairs, Safety and Pharmacovigilance (GRASP) with approximately 80 colleagues based at our headquarters in Hørsholm.As Regulatory Compliance Assistant, you will support the Compliance & Operations team with key administrative and operational tasks across regulatory systems. Your responsibilities will include maintaining training documentation in LearnIT and QualityDocs, assisting with data entry and quality control in Veeva Vault RIM, and helping the formatting and update of regulatory procedures and guidance documents. You may also contribute to exciting digitalisation and AI initiatives, and support coordination and follow-up on team and departmental activities.Responsibilities:

• Support training documentation tasks in our Learning Management system LearnIT.
• Support document management in our eDMS Veeva QualityDocs.
• Perform data entry and quality control in Veeva Vault RIM and other regulatory systems.
• Assist in updating and formatting Standard Operating Procedures (SOPs), Work Instructions (WINs), and internal guidelines.
• Contribute to digitalisation and AI-related projects in the department.
• Help coordinate team meetings, document follow-ups, and track deliverables.

Your profile
You are likely at the beginning of your professional journey – perhaps in a gap year or between your bachelor’s and master’s degree. We don’t expect industry experience; the most important thing is that you are curious, reliable, and comfortable using digital tools.We expect you to have:

• • A structured and detail-oriented mindset, especially when working with documentation and data.
• • A proactive, service-minded attitude and interest in supporting colleagues.
• • Strong IT affinity and the confidence to learn new digital tools and systems.
• • Fluency in English (Danish is a plus, but not required).
• • A positive and engaged mindset – and a willingness to learn and grow.

Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values development of skills and knowledge.We offer a temporary contract for a minimum of 12 months with possibility of extension. Contract start is flexible and can be after the summer holidays (August/September).Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home. Do you want to learn more about our company, we encourage you to visit us at www.alk.net.Apply
Apply by attaching your CV and a short letter of motivation, no later than 15 June 2025.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We evaluate applications and call for interviews throughout June, so don’t wait to apply!For further information regarding the position please contact Sr. Manager, Jesper Kærgaard Kristensen on telephone +45 41 95 90 72.We are looking forward to hearing from you!Send applicationShare on:Region:

• Region Hovedstaden

Job type:Fixed Term ContractWorking hours:Full-timeWorking days:DayIndustry sector:Regulatory AffairsJob level:EmployeePosition type:AssistantApplication deadline:15/06/2025Location:Hørsholm, DenmarkCompany homepage:Office address:Bøge Allé 1 2970 HørsholmOffice location:ALK-Abelló A/SALK helps people living with allergy. By providing solutions that make life with allergy surprisingly simple we make a difference for many people. We build upon a strong heritage as a pioneer in allergy immunotherapy and we will continue to innovate, develop and market new products and solutions for people with allergy.
ALK is a global company with production sites in Denmark, France, Spain and the United States. We were founded in Copenhagen in 1923. Headquartered in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and is listed on Nasdaq Copenhagen.
We know that our employees are our most valuable asset and we believe they do their very best every day in the pursuit of new and better allergy treatments and solutions for people with allergy around the world. If you like to have influence and make a difference ALK is the right place so come join us on our exciting journey.

Expected salary:

Location: Hørsholm, Hovedstaden

Job date: Thu, 29 May 2025 05:25:44 GMT

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