Director of Regulatory Affairs – Copenhagen, Denmark
We are working with a joint venture created by one of the world’s largest designers and manufacturers of advanced drug delivery systems for the pharmaceutical & biotech markets and a leading global developer, manufacturer and supplier of Active Pharmaceutical Ingredients and Finished Dosage Forms.
The technology is based around a new, world beating respiratory inhaler. In our opinion, this inhaler is years ahead of anything else currently on the market. We have seen it in action and it is a game changer. It is already in clinical trials with first product launch expected in 2021.
The company is well found, well-funded with a start-up mindset. A small company making a big difference with a game changing technology and real products (currently there are programmes in Asthma, CF and COPD with two combination products ready to be marketed).
We are now looking to build the senior management team to be based in Copenhagen, Denmark and wish to appoint a Director of Regulatory Affairs, someone with:
- a deep understanding of the regulatory requirements for inhaled pharmaceutical products, device registration and CE marking
- hands-on experience in the preparation and submission of a registration dossier for EU and/or US
- EMA/FDA regulatory experience who understands how to devise clinical trials for inhaled drug delivery combinations and has brought at least one inhalation device / drug combination product to market.
Although we require a background in regulatory affairs within the pharmaceutical industry, this is a role for a small team player. Someone with pharmaceutical company experience, a proven track record in pharmaceutical inhalation projects and at least one project that has been filed/approved by regulatory authorities, ie from R&D through to post registration.
Interested? E-mail: [email protected]