Associate, RA Submissions & Operations

We are looking for a detailoriented RA Associate who thrives on coordinating both administrative and complex regulatory 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 departments 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 employees 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 Europes largest parallel importer of pharmaceuticals and Denmarks largest supplier of pharmaceuticals with more than 2200 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: 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: