Senior 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 Senior Regulatory Affairs Specialist in the Post Approval CMC team.
About the job
As Senior 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 solid 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 you have the possibility to work from any Orifarm office and further, you have the flexibility to work partly from home as well.
Starting out with a strong entrepreneurial mission, Orifarm was founded in 1994 by Birgitte and Hans Bøgh-Sørensen. The underlying explorer spirit still characterises the company, and with high ambition, we are constantly looking for new opportunities and business areas to invest in. Our purpose of being is to create competition and provide important savings for society and to ensure better value for money for consumers. We strive to make this happen while insisting on being good colleagues, improving together, helping each other, and innovating.
We operate within seven business areas: Over the Counter (OTC), Consumer Healthcare, Generics, Promotional Rx, Unlicensed Medicines, Parallel import and Clinical Trials Supplies (CTS). We are the largest parallel importer of pharmaceuticals in Europe as well as the largest supplier of pharmaceuticals in Denmark. We hold a strong position in Generics in the Nordics, being the largest producer of over-the-counter medicine in Denmark. Moreover, within New Bizz, we aim to expand our business by exploring new opportunities within pharmaceuticals.
In Orifarm we place great emphasis on both your professional and personal development and on giving you the opportunity to bring all of your skills into play.
We offer a competitive compensation and benefits package and our staff canteen offers a variety of healthy menus every day. Physiotherapy will also be at your disposal.
In case you have further questions, please contact Team Manager Aileen Koch by mail firstname.lastname@example.org
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