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Administrative Associate, RA Submissions & Operations

icon building Company : Orifarm
icon briefcase Job Type : Full Time

Job Description - Administrative Associate, RA Submissions & Operations


We are looking for a detail‑oriented and reliable colleague who thrives in both administrative tasks and ensuring coordination with stakeholders.
In this role, you combine a strong IT aptitude with structure and precision.


 


An Administrative Associate in the RA Submissions & Operations team is responsible for executing and coordinating regulatory operations within key regulatory systems, ensuring data integrity, compliance, and timely submissions. The role contributes directly to maintaining product licenses and supporting business objectives across multiple markets.


 


About the job


Main tasks and responsibilities, including but not limited to:



  • Handling approvals of variations and preparation of administrative variations (e.g. withdrawals), updates of Regulatory Compliance Files, etc. thus ensuring accurate and smooth processes

  • Managing documentation, archiving, and database records e.g. in internal RIM, Veeva Regulatory suite, Veeva Quality suite and EXTEDO eCTD Manager

  • Ensuring timely published and submitted eCTD sequences for Marketing Authorisation Applications and variations to the Health Authorities


 


Who are you? 



  • Have a background in healthcare (e.g. nurse, midwife, pharmacy, clinical trials, healthcare administrator, or a related field)

  • Are proficient in both written and verbal English (B2)

  • Show a general aptitude for IT

  • Shows team spirit and is service minded

  • Demonstrate advanced co-ordinational abilities in interacting with a wide range of stakeholders, both internally and externally

  • Work confidently on your own, yet value sparring with teammates at an early stage to strengthen outcomes


 


Who are we? 


The RA Submissions & Operations team consist of two sub-teams, where this position is in the operational part of the team. You will be working closely with teammates located at both the recently opened Warsaw office and at the Odense Headquarter in Denmark.


The communication and collaboration in the team and throughout the RA department is open and informal, with an appreciation for a healthy balance between focused handling of tasks and social interaction.


 


What we offer:



  • Full-time employment contract

  • Annual bonus

  • Life insurance

  • Private medical care

  • Subsidy to a sports card

  • PPK

  • Hybrid work model

  • Flexible working hours


 


Job Location


Warsaw, Poland. Hybrid work model – 3x/week from the office located at Inflancka 4A.


 


Application deadline


ASAP.
Applications will be assessed ongoing until the position has been filled, first interviews are expected in October 2026.


 


Why should you join Orifarm?


At Orifarm, we are united by a shared purpose: improving access to affordable medicine for the people who need it. Founded in Odense in 1994 by Birgitte & Hans Bøgh-Sørensen, we have built our business on challenging conventional thinking to make affordable high-quality pharmaceuticals more accessible across Europe. Rather than developing new medicines, we focus on finding smarter ways to bring existing treatments to patients, creating value for pharmacies, healthcare systems, and society.


We live by the mindset Challenge Accepted. It reflects our explorer spirit and can-do attitude, where challenges are perceived as opportunities. We encourage people to ask questions, challenge assumptions, and take ownership. Across teams, functions, and markets, you will find a collaborative and supportive culture built on trust, respect, and a flat hierarchy where everyone has a voice and direct access to decision-makers.


When you join Orifarm, you will be empowered to make a real impact from day one. We offer autonomy and great opportunities for career advancement, enabling our employees to shape their professional development.  We value flexibility and provide a hybrid work model with the possibility of working from home two days a week.


We invite you to join Orifarm, if you are curious, ambitious, and accept the challenge of bringing better deals of medicine to millions.


 


We encourage everyone to apply 


At Orifarm, we welcome people from all backgrounds, recognizing that the best outcomes come from a diverse and inclusive work environment. Our commitment is to create an environment where different perspectives and skills drive innovation and contribute to a sustainable future. By creating such an environment, we are confident that we can achieve better results together. 


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