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.
In 2017 we appointed a Managing Director to spearhead the launch, growth, development and operational roll out of this completely new business area. 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, it is a game changer. It is already in clinical trials with first product launch expected in 2021.
We are now looking to build the senior management team to be based in Copenhagen, Denmark and initially wish to appoint a Director of Regulatory Affairs.
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).
This is an opportunity to build a new business within two well-established companies, with the necessary money, infrastructure and support, and make it your own.
Requirements:
We need someone who has personally been directly involved in taking an inhalation product to market and endured all the heartache of Drug Development, Device Development, Regulation, Registration and Product Launch, including:
· 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.
Please email your CV/Resume to:
David Wallder – david@wallder.com
