Senior Regulatory Affairs Specialist, Product Development
Do you like to use all aspects of your chemical, clinical and pharmaceutical knowledge together with your experience in regulatory affairs? Do you at the same time wish to be part of a dynamic organisation that is constantly growing and changing, and with good development opportunities? Do you like to be in close collaboration with other regulatory specialists, development departments, quality control, business development and a wide range of external partners and authorities, then you might be our new (Senior) Regulatory Specialist in Orifarm Generics, Regulatory Affairs, Product Development.
About the job
As (senior) regulatory specialist you will be involved in the regulatory strategy for our applications, both for our own-developed products and out-licensing of these, as well as for in-licensing products. You will be involved in compiling and submitting new marketing authorisations applications (MAA) to the authorities. You are also responsible for answering questions from the authorities in collaboration with manufacturers and with colleagues in the department. You are responsible for coordinating the approval procedures up to the marketing authorisation.
For our own-developed products you will contribute to the development process of the product with your regulatory knowledge as well as your pharmaceutical and chemical knowledge. You will be participating in preparation of method validation, process validation, stability documentation and evaluation of data. With the major acquisition Orifarm had earlier in 2021 you will also be part of updating dossiers to make them ready for out-licensing and for submission of marketing applications in new countries.
You will be responsible for writing the documentation for the own-development product dossier, in close collaboration with QA, QC and our production units.
Would you also like to participate in clinical work with biostudies, it will also be an opportunity.
For in-licensing products you will, besides the regulatory strategy, review product dossiers as to whether they meet rules and guidelines of the European authorities, to have them updated before submission of the MAA. For some in-licensing products you might also contribute in their development of the products, and evaluate and comment on their data.
We expect you hold a relevant education as Cand. Pharm., Cand.Scient. or equivalent. You are open minded and honest, have a good sense of humour and a positive outlook on life. You thrive on having a lot of balls in the air and with the fact that there are constantly new tasks and deadlines that must be met. You manage to work detail oriented when required and at the same time maintain an overview of the whole. You formulate your clearly both in Danish and English. You have experience with drug registration. Experience and interest in pharmacology, biopharmaceuticals (incl. drug absorption and pharmacokinetics), clinical studies and/or medical writing will also be an advantage.
Who are we?
You will be part of the Product Development Team in Regulatory Affairs Generics which I responsible for the regulatory strategy of the products, compilation of most of the dossier and for submitting the new marketing authorisation applications. The team consists of other highly dedicates regulatory affairs specialists. We work closely together to ensure high performance and the best service to the rest of the organisation. At Orifarm we have high ceilings and an informal tone, and we work continuously to maintain our values and culture.
Starting out with a strong entrepreneurial mission, Orifarm was founded in 1994 by Birgitte and Hans Bøgh-Sørensen. The underlying explorer spirit still characterizes 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 three main business areas: Parallel Import, Generics & OTC, and New Bizz. We are the largest parallel importer of pharmaceuticals in Europe and the largest supplier of pharmaceuticals in Denmark. We hold a strong position in prescription medicine in the Nordics, being the largest producer of over-the-counter medicine in Denmark. Our portfolio contains well-known brands such as Pamol, Kodimagnyl, and Apovit. 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 allowing you to bring all of your skills into play. Our headquarter is in Odense and we also have a newly established office in Søborg, Copenhagen. You will be able to work from both locations. We offer a competitive compensation & benefits package and our staff canteen offers a variety of healthy menus every day, and physiotherapy will also be at your disposal.
If you need further information about the job please contact Team Manager Mette Vorup Møller at phone +45 81 88 56 41.
Application deadline:As soon as possible