Specialist, Regulatory Affairs Labelling

Category: Regulatory Affairs
Country/Region: DK
Location: Søborg, DK, 2860 Odense, DK, 5260

We are looking for a colleague who is passionate about Regulatory Affairs, has a positive drive, and wants to use all of their medical and pharmaceutical knowledge and experience in a dynamic organization with great possibilities for professional and personal growth.
About the job
We are looking for an RA Specialist for our Labelling Department. The department's purpose is to "develop and maintain product information and artwork following regulatory requirements and commercial demands supporting the launch and release of goods and ensuring patient safety."

We are looking for someone who is focused, detail-oriented, and independent. In this position, you will have to juggle and structure various tasks. With both internal and external stakeholders having different backgrounds and professions, you do not hesitate to bring yourself and your knowledge into play and contribute to a good and open working environment.

Additional tasks and responsibilities include, but are not limited to:

• Creation of product information (SmPC, labelling and patient leaflets) for marketing authorization.
• Proofreading and approval of product information and artwork/mock-ups
• SmPC comparisons
• Monitoring and implementing European legislation
• Correspondence with internal stakeholders and Authorities

Who are you?
You are open, honest, dedicated, and willing to contribute your professional and personal competencies. You are a strong team player who wants to join a team and build new relationships but also has the ability to work independently. Furthermore, you are a good communicator and a great collaborator. Experience with regulatory affairs is an advantage but not a must.

Additionally you are:

• A pharmacist, Cand. Scient. or have a similar education preferable within pharma
• Fluent in both written and verbal Danish and English
• In possession of great analytical, coordinating and problem-solving skills
• Paying attention to details and having a GxP and a commercial mindset
• Able to adapt to changes in a dynamic and fast paced working environment

Who are we?
We are a labelling department with around 12 dedicated regulatory professionals divided into two teams (Development and Life Cycle Management). We value a casual, positive, and humorous tone and make room for laughter and seriousness. The working environment is exciting and dynamic and is characterized by everybody taking responsibility for their own areas while helping each other and sparring on both a professional and personal level.

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. Additionally, you can enjoy a great canteen with various delicious and healthy meals at our offices and take advantage of the massage service available at our office in Odense. 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.

Job Location
We would like to welcome our new colleagues start January or as soon as possible thereafter. You will be working from either our Søborg office or the headquarter in Odense with the flexibility of working partly from home as well.

Need further information?
If you need further information about the job please contact Department Manager, Pernille Struck via e-mail [email protected] or by phone +45 30209067.

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/.

Application deadline
Please apply before 22th of November. Interviews will be held on an ongoing basis.