Director of Regulatory Affairs

Required: Demonstrated in-depth understanding of and experience submitting 505(b)(2) applications to the FDA

Strawn Arnold has been retained to recruit the Director of Regulatory Affairs for a global specialty pharmaceutical company engaged in the development and commercialization of 505(b)(2) pharmaceutical products.

The Company is looking for an experienced Director of Regulatory Affairs with prior experience with the submission and approval of 505b2 products to the US FDA. The role has dual reporting to the top Commercial Officer in the US and the Global Head of Regulatory Affairs based in Europe. The successful candidate needs the confidence to work independently and be able to interact and navigate a global organization. Initially this is an individual contributor role.

This is a key position as the Company expands into the US. The Director will be on the leadership team for the US and part of the global regulatory organization. Critical success factors will include the ability to work in a fluid, rapidly evolving organization where the ability to be hands on is important. We have a full role profile to share with qualified candidates.