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Job #02695

About our client Our client is a privately owned specialty pharmaceutical company focused on the design, development and commercial manufacture of sterile, injectable, sustained release pharmaceuticals. Products of this class have extremely high commercial potential. Our client concentrates exclusively in this drug delivery space. They are advancing their lead products, and building successful partnerships with major and specialty pharmaceutical companies worldwide. Position Location Director (Scientific and Regulatory Affairs) Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Collaborate with senior management on (relevant) long-term regulatory objectives and concerns 2) Identify and anticipate the impact of revised regulations and guidelines on the company’s strategies 3) Provide regulatory strategy inputs to assist in developing realistic and efficient objectives 4) Establish strategies for the effective and efficient submission of regulatory documents 5) Provide guidance on most current, correct content and format to ensure compliant submissions and filings 6) Communicate approved plans within the company and to external contacts 7) Provide support and assistance to individuals responsible for generating information for submissions 8) Ensure that all CMC documentation requirements are met 9) Implement changes (when needed) and resolve problems 10) Maintain current knowledge of all scientific regulatory requirements 11) Identify changes that do/may affect current or future projects 12) Apprise top management of progress, significant events/issues and results of the department 13) Ensure resources that are created/obtained for efficiency 14) Remove obstacles and address problems that hinder the accomplishment of desired results 15) Identify short- and long-term issues as well as recommend options and courses of action Requirements 1) 10 years of recent experience in the US pharmaceutical drug development and manufacturing industry with an emphasis on clinical and non-clinical disciplines (subject to multiple aspects of FDA laws and regulations) 2) Minimum 5 years of experience in a management-level position 3) Experience in motivating and coordinating multi-disciplinary functions to accomplish successful registration of new drugs 4) Experience in licensing (in and out) and business development in the pharmaceutical industry 5) International drug development setting experience a plus 6) Experience in regulatory filings and submissions, related to client’s strategic focus (mainstream pharmaceutical company preferred) 7) Experience in collaborating business development (internal and external), pilot plant and manufacturing to bring new products to the market 8) In-depth knowledge of CMC content and requirements along with cGMP regulations 9) Superb IND, NDA and ANDA preparation and documentation as well as regulations and policies of labeling, marketing and advertising of products expertise 10) Extensive FDA communication experience