Associate, RA Submissions & Operations

We are looking for a detail‑oriented RA Associate who thrives on coordinating both administrative and complex regulatory tasks. In this role, you combine strong stakeholder management as well as IT skills with a solid grasp of the pharmaceutical industry, ensuring timely submissions, accurate documentation, and smooth compliance processes.

About the job

An Associate in RA Submissions & Operations performs a diverse array of tasks to support the various teams within the Regulatory Affairs Department, aligning with business needs. During periods of high demand, they provide enhanced support to the Regulatory Affairs teams in both administrative and specialized tasks. 

Main tasks and responsibilities, including but not limited to:

• Ensuring timely published and submitted eCTD sequences for Marketing Authorisation Applications and variations to the Authorities
• Proofreading of documents regarding safety and quality variations
• Handling approvals of variations, autonomously handling of administrative variations (e.g. withdrawals), updates of Regulatory Compliance Files, and various administrative tasks
• Assuming trainer roles in one or more areas of the department’s responsibilities, ensuring knowledge transfer and skill development through knowledge sharing
• Daily responsibilities in systems such as e.g. the Veeva RIM Suite and EXTEDO eCTD Manager

Who are you? 

• You have between 1 to 3 years of experience in Regulatory Affairs
• Demonstrate advanced abilities in interacting with a wide range of stakeholders, both internally and externally
• Are service minded and holds a high degree of co-ordinational skills
• Possess a solid understanding of the pharmaceutical industry and general knowledge of Regulatory Affairs
• Work confidently on your own, yet value sparring with teammates at an early stage to strengthen outcomes
• Are proficient in both written and verbal English
• Show a general aptitude for IT
• Professional training/education or experience within healthcare is considered an asset

Who are we? 

The RA Submissions & Operations team consist of two sub-teams, where this position is located in the publishing 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 in the RA department as a whole is open and informal, with an appreciation for a healthy balance between focused handling of tasks and social interaction.

What we offer:

• Fulltime employment contract
• Annual bonus
• Life insurance
• Private medical care
• Sports card
• PPK
• Hybrid work model
• Flexible working hours

Job Location

Warsaw, Poland. Hybrid work model – 3x/week from the office located in the prestigious Gdański Business Center at Inflancka 4.

Application deadline

ASAP. We will start reviewing applications in December 2025.

Why should you work for Orifarm?

At Orifarm, we know that our growth comes from the development of our employees. We are an ambitious organization with an entrepreneurial culture celebrating can-do attitudes, smarts, and hearts. Our secret to success? Valuing how different skill sets join forces to make our journey happen.

You will experience a work environment characterized by flexibility and a strong commitment to work-life balance, understanding that the best results come from satisfied and well-supported employees. Our international setting offers great opportunities for growth and career advancement. We also prioritize social events and gatherings to ensure that our employees feel connected and engaged with each other.

We regard our feedback culture as a fundamental element in the individual employee's opportunities for learning and development. When we have good results, every employee, including student workers, is part of our bonus scheme.

About Orifarm

Everyone should have access to modern medicine. High costs or lack of access to pharmaceuticals should never impact our possibility to receive treatment or relief and live a healthy life. At Orifarm, we aim to bring healthy days by making modern healthcare a better deal for the people and the societies we serve. Working towards our vision, we create access to affordable, high-quality pharmaceuticals and healthcare products by challenging markets and always seeking new opportunities. With our core values paving the way, we always act responsibly and constantly with our customers at the center of our attention. And everything we do is driven by our sole purpose:

For as many as possible, as healthy a day as possible.

Our history goes back to 1994 when Orifarm was founded in Denmark by Hans and Birgitte Bøgh-Sørensen. Since then, Orifarm has grown from a small nine-person company into an international company operating globally in 15 countries. Today, Orifarm is Europe's largest parallel importer of pharmaceuticals and Denmark's largest supplier of pharmaceuticals, with more than 2,200 employees.

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.

We are often looking for new employees to help us grow and therefore, we may have other interesting opportunities for you. Follow us on LinkedIn to receive updates on our business activities and job opportunities: https://www.linkedin.com/feed/. Alternatively, if we do not have any vacant positions that match your interests at this time, we encourage you to submit your resume to our talent pool, from which we continuously select candidates: https://careers.orifarm.com/lp/TalentPool/28c5a1691eef5fd4/.