Specialists, Regulatory Affairs Life Cycle Management
- Structured specialists with strong quality focus and stakeholder management skills
Are you passionate about Regulatory Affairs Life Cycle Management? And do want to use all parts of your chemical - and pharmaceutical knowledge and experience in a dynamic organisation with great possibilities for professional - and personal growth? If you manage to juggle and structure various tasks in collaboration with diverse internal and external stakeholders, where you bring yourself and your knowledge into play, you may be the right match for one of these two positions.
About the job
We are currently looking for two Regulatory Affairs Specialists, one for our Project Management and Launch team and one for our CMC team. These teams are organised in Regulatory Affairs Life Cycle Management which holds the regulatory responsibility for our generic portfolio after the receival of the marketing authorisation. We put an honour in keeping all our marketing authorisations and dossiers up to date making sure that every product throughout all of its lifetime lives up to the current legislation. This is done in close cooperation with local Regulatory Affairs professionals throughout Europe, such as European authorities and internal colleagues from Quality, Purchase, Development, Labelling, Sales and more.
Project Management and Launch handles the more overall regulatory tasks related to the lifecycle of the products whereas CMC focuses on our generic products produced at external partners as well as maintenance of the marketing authorization. Generally, as a Regulatory Affairs Specialist, you will cooperate with internal and external stakeholders, such as authorities, external suppliers and colleagues from various departments. Further, you will initiate internal change controls and monitor and implement European legislation.
As a Regulatory Affairs Specialist within Project Management and Launch, some of your main tasks will be to:
- Support launch of new products and maintain life cycle activities on our existing portfolio (quality variations, renewals, withdrawals etc.)
- Maintain and develop internal regulatory procedures as well as to maintain and implement new and existing IT systems
As a Regulatory Affairs Specialist within CMC, some of your responsibilities will be to:
- Handle module 3 variations
- Review and/or author CMC documentation
- Contribute to the regulatory strategy
- Evaluate external change controls
Who are you?
We imagine that you are a pharmacist, Cand. Scient. or have a similar education. As you will interact with various stakeholders, you are a good communicator and are able to collaborate with all kinds of people. Additionally, you are a strong team player, but also willing and able to take responsibility and work independently.
We expect you to be:
- Ambitious on behalf of yourself and your colleagues
- Fluent in both written and verbal English
- In possession of great analytical and coordinating skills and being able to see both the details and the bigger picture
- In possession of a positive view on life and a good energy contributing to a good an open working environment
- Interested and experienced within IT systems
Experience within pharmaceutical production and/or regulatory affairs is an advantage.
Who are we?
Over the past two years, Orifarm has grown rapidly growing, and lots of new tasks and challenges have arisen due to an acquisition resulting in a double size portfolio. Likewise, the organisation and processes in Regulatory Affairs Life Cycle management have developed, and these two newly established teams are a result of it.
Project Management and Launch is a team of seven skilled and dedicated regulatory professionals all situated in Odense. Two of the team members are, at the moment, on maternity leave. We value a casual, positive and humoristic social tone, and we make room for both laughter and seriousness. The working environment is exciting and dynamic and is characterised by everybody taking responsibility for own areas and at the same time helping each other and sparring on both a professional - and personal level.
CMC is a team of eight skilled and dedicated regulatory professionals situated in Odense and Søborg. We value a casual, positive and humoristic social tone and we make room for both laughter and seriousness. The working environment is exciting and dynamic and is characterized by everybody taking responsibility for own areas and at the same time helping each other and sparring on both a professional - and personal level.
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.
It is possible for you to work from any Orifarm office and further, you have the flexibility to work partly from home as well.
If you need further information about the job, please contact VP RA Healthcare Anja Devantier via mail email@example.com or by phone +45 22996334.
Application deadline:As soon as possible