Seneste jobinformation fra Abacus Medicine Group til stillingen som Senior Regulatory Affairs Specialist, HUB. If the Senior Regulatory Affairs Specialist, HUB ledige stilling i Danmark matcher dine kvalifikationer, bedes du indsende din ansøgning eller dit CV direkte gennem den opdaterede Jobkos jobportal.
Bemærk venligst, at det ikke altid er nemt at søge job, da kandidater skal opfylde visse krav sat af virksomheden. Vi håber, at karrieremuligheden hos Abacus Medicine Group til stillingen som Senior Regulatory Affairs Specialist, HUB nedenfor matcher dine kvalifikationer.
Senior Regulatory Affairs Specialist, HUB
Join to apply for the Senior Regulatory Affairs Specialist, HUB role at Abacus Medicine Group.
Recruitment | Headhunting | Search | Global Talent Acquisition Partner – we still haven’t filled all the Stillings in the team of 8 new Specialists, so if you speak Finnish, Norwegian, Swedish, or Icelandic, please don’t hesitate to apply!
The opportunity
As our Senior Regulatory Affairs Specialist, you will be responsible for obtaining and maintaining parallel trading licenses and preparing packaging materials according to SOPs, WIs, and applicable guidelines. Your work will ensure regulatory compliance, smooth production processes, and timely market access. You will handle dossiers, artwork, and documentation, while also staying up to date with regulatory requirements in your assigned end market.
We would like you to
Prepare and submit dossiers to acquire and maintain parallel trading licenses.
Create and maintain packaging materials, artwork files, mock‑ups, and item lists.
Proofread packaging components, application files, and item lists to ensure accuracy.
Manage and archive regulatory documentation, including packaging materials and authority‑approved files.
Communicate directly with health authorities and external printing houses, monitor regulatory updates, and implement changes as required.
Contribute to continuous improvement projects, training, and updates of working instructions and guidelines.
Handle ad‑hoc assignments from your manager.
About you, our new colleague
We are looking for a detail‑oriented and proactive professional who thrives in a structured, regulated environment and enjoys collaborating with multiple stakeholders.
You bring
A Master’s or Bachelor’s degree in Pharmacy, Regulatory Affairs, Life Sciences, or an equivalent field.
Minimum 2 years of experience in the pharmaceutical industry.
Fluency in either Finnish, Norwegian, Swedish, or Icelandic (written and verbal) and good knowledge of English (written and verbal).
Experience in at least one of the following areas:
QA or RA within pharma.
Interaction with regulatory authorities.
Handling medicine forms and packaging materials in repackaging processes.
Experience with repackaging processes and machinery.
Proficiency in Adobe InDesign, Illustrator, Photoshop; knowledge of EULER (braille) and text comparison software.
Skills and competencies that will make you succeed
You have strong knowledge of regulatory dossiers and parallel distribution procedures and a solid understanding of packaging material design, proofreading, and archiving. You communicate effectively with authorities and external partners, and your work is characterised by accuracy and attention to detail in regulatory submissions. You are able to perform under strict guidelines and deadlines, while also maintaining a continuous improvement mindset, always seeking opportunities to optimise processes and systems.
Are you interested?
We’d love to hear from you if you want to be part of an international team ensuring compliance, efficiency, and patient safety. Please submit your CV via our career page. We look forward to receiving your application!
Do you want to know more Om os?
Follow us on Instagram and LinkedIn and get an insight into everyday life at Abacus Medicine. For job openings, check our Career page.
Moving Healthcare. Moving You.
In Abacus Medicine Group, you’ll experience the power of Moving Healthcare. With our change mindset we’re moving the industry and improving healthcare as we broaden access to medicine. It's not just about moving healthcare, it's about Moving You. You’ll be part of a caring community of more than 1,500 people across the world. With us, you will be valued, empowered, and have a direct impact on driving change.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Legal
Industry
Pharmaceutical Manufacturing
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