Specialist, Regulatory Affairs
Do you want to become part of a dynamic organisation with many opportunities for personal and professional development? Do you enjoy combining your knowledge of chemistry and pharmaceutical science with regulatory work and do you have experience in lifecycle management? Then you might be the right match to the position as Regulatory Affairs Specialist in the Post Approval CMC team.
About the job
As Regulatory Affairs Specialist, you will be responsible for lifecycle management of products manufactured at Orifarm’s own manufacturing sites. Therefore, you will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales.
Further, your main responsibilities include to:
- Gather information and documentation for variation applications
- Update dossier sections
- Prepare variation applications and response
- Ensure compliance with European as well as regional legislation and guidelines
- Use your pharmaceutical and chemical knowledge to review and approve documentation, such as stability protocols/reports and method or process validation protocols/reports
Further, you will be involved in product optimisation, and you will play a key role in transferring the manufacturing processes and analytical methods across our own manufacturing sites by providing the regulatory input.
Who are you?
The right match for this position is a Pharmacist, Cand. Scient. or similar with experience in CMC, either in Development or Lifecycle Management.
You work in a structured manner and are capable of joggling different tasks and deadlines. It is important that you are a team player who has the capability of working independently as well.
We value honesty and a positive mindset as well as a good sense of humour.
Additionally we expect you to:
- Have a commercial mindset
- Communicate professionally in English, both written and spoken
Danish skills are an advantage
Who are we?
We are the so called “Team in the middle”, collaborating closely with our colleagues in Odense, Søborg, Skælskør, Hobro and Łyszkowice. We are based at our Headquarter in Odense, but it is possible to mainly work from our office in Søborg as well, and usually we spend two days a week in our home offices.
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. In 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 in 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 where 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 13 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 operate within seven different business areas: Over the Counter (OTC), Consumer Healthcare, Generics, Promotional Rx, Unlicensed Medicines, Parallel Import and Clinical Trials Supplies (CTS). Further, we focus heavily on new business opportunities and synergistic M&A to expand our offerings
At Orifarm, we know our growth comes from the growth of our employees. We are an ambitious organization with an entrepreneurial culture, and we celebrate can-do attitudes, smarts and hearts. Our secret to success? Valuing how different skillsets join forces to make our journey happen. Whether you play a direct or an indirect part of fulfilling our purpose, you get to contribute and use your skills, personal as well as professional. Indeed, at Orifarm your personal growth journey is shaped only by your contribution towards making healthy days for as many as possible.
We regard our feedback culture as a fundamental element in the individual employee’s opportunities for learning and development. And when we have good results, every employee, including student workers, are a part of our bonus scheme.
Mainly depending on your preferences, the job will either be located at our headquarter in 5260 Odense or at our office in 2860 Søborg.
Need further information?
In case you have further questions, please contact Director RA LCM, Bettina Twile via mail: firstname.lastname@example.org or phone +45 24 44 08 57.
Due to GDPR requirements, this e-mail address should be used for elaborative communication. Applications submitted via mail will not be taken into account. Please use the electronic application system.
Application deadline:As soon as possible