Exceptional opportunity to join a well established and successful pharmaceutical company in Philadelphia. They are the perfect sized company - large enough to provide resources and stability, but small enough to offer HIGH VISIBILITY and the opportunity to make an IMPACT on the continued success of the company. Their product portfolio includes over 20 proprietary pharmaceuticals and is growing due to their robust product pipeline. Revenue in 2005 exceeded $1 billion and they are listed on the NYSE.

In this CRUCIAL ROLE you will be responsible for strategic and tactical plans and implementation for regulatory affairs for new product development registrations, marketed products and licensing opportunities. Will interface with the FDA concerning pre-clinical and clinical development issues. Responsible for timely submission of clinical portion of INDs and NDAs. Will lead a small team of professionals and be responsible for their growth and development.

Requires PhD with 7 to 10 years experience in Regulatory Affairs or other combinations of education and experience. Must have in-depth knowledge of FDA regulations and drug development process. Also a track record of FDA approvals of IND and NDA submissions and working directly with the FDA. Need prior management experience to lead small group of professionals. Critical to have an entrepreneurial mind-set, as well as the flexibility for hands-on activities when necessary. Well developed communication skills are expected. Local candidates are highly preferred.

Client offers attractive compensation and benefits, including best in industry 401K plan and much more. If fully qualified submit your resume in confidence to julie@advantage-search.com as an MS Word doc. If this opportunity isn't right for you please refer a colleague. We look forward to working with you for a win-win outcome.