FierceBiotech and FiercePharma Jobs
VP Regulatory Affairs & Quality Assurance - Erdman Biotech Recruiters, Inc.
Oct 13
Location: Cambridge, MACategories: Pharmaceutical
Website: http://www.erdmanbiotechrecruiters.com
Position Description
Are you interested in joining a small, boutique pharmaceutical company that has just launched one drug outside of the US, and is working on the US filing? Have you run a Regulatory Affairs group at a small company before? Do you have experience coordinating both US and European submissions?
This small, public pharmaceutical company which is located in Cambridge, MA, is searching for a top executive for VP of Regulatory Affairs & Quality Assurance. This role reports to the CEO. The company focuses in the pain management area. In addition, this company is in Phase III trials of an additional drug that is headed for a NDA submission.
The Vice President will provide regulatory advice and strategy to management , and regulatory guidance and support to development teams within the organization. They will also coordinate submissions and FDA and European interaction. They will also serve as liaison between license partners and business development, on behalf of product development.
Qualifications:
The ideal candidate will be a strong manager with excellent communication and organization skills. A solid understanding of, and experience with, FDA regulations and guidelines, as well as considerable exposure to the regulatory review process, is essential. A demonstrable track record of leadership and the ability to interpret complex clinical data for agency submission and/or publication is needed. Experience with bringing products to the European market and knowledge of EU regulations and guidelines is also required. A PhD or MD is preferred for this role.
Total compensation is commensurate with experience.
We’re looking for people that are looking for an energetic, small company with NDAs looming and great experience on the regulatory side. You would be leading the company throughout the NDA and launch process!
Keywords: Novartis, AstraZeneca, GlaxoSmithKline, Wyeth, Merck, Cephalon, Endo, Pfizer, Purdue Pharma, CombinatoRx, Cubist, Alkermes, ARIAD, Sanofi-Aventis, Roche, BiogenIdec, Millennium, Genzyme
