Associate Director Regulatory Strategy

Associate Director Regulatory Strategy GI/GU

The incumbent to the Associate Director Regulatory Strategy position will provide regulatory strategic direction for the global development and implementation of regulatory activities for one or more projects; responsible for multi-disciplinary or multi-faceted development programs (i.e. multiple indications for a given compound), supervises, trains and provides technical and regulatory guidance to staff, provides regulatory therapeutic area strategic guidance on development projects and marketed products, develops regulatory development plans and manages plan execution, represents the company at regulatory meetings and interact with all levels of FDA within the division(s) of responsibility. The director provides strategic direction for the global development and implementation of regulatory strategies for the products of responsibility, provides oversight to ensure regulatory compliance of marketed products, provides strategic direction for FDA meeting preparations, including FDA Advisory Committee Meetings, negotiates regulatory issues with the FDA at the Division level and state regulatory agencies as required, provides product development strategy and manages the implementation of regulatory strategies to meet project goals for specific drug development projects, provides regulatory leadership for the preparation and submission of major regulatory submissions, evaluates regulatory risks for projects and make recommendations relative to the overall program strategy, as assigned is responsible for "due diligence" and feasibility assessment of drug development candidates and manages others drug development regulatory professionals. The ideal candidate will have the following skills and experiences: BS/BA Degree required, master's or other advanced degree preferred, 10 years of experience in the pharmaceutical industry or regulatory agency experience, 8 years of regulatory experience, 4 years of progressive management experience, knowledge of FDA regulations and global regulatory environment, previous experience in drug development, ability to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for new product development, functions independently as a decision-maker on regulatory issues, understands regulatory, quality and safety systems impacting drug development and marketed product support as well as willingness to travel to various meetings or client sites, including overnight trips; some international travel may be required, requires approximately 20% travel.

Please refer to job code SD5932 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Lincolnshire, IL
County:	Lake County
ZIP Code:	60069
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856