This specialty biopharmaceutical client understands the importance of recruiting the very best people at every level of the organization. They emphasize a culture that encourages teamwork and achievement. Bureaucracy has no place in their culture.

Responsible for preparing, implementing, communicating and coordinating regulatory projects, plans and schedules with scientific, manufacturing, marketing and business development teams for biological and drug products. Will lead a team of Regulatory Affairs and Quality professionals to further product development and ensure regulatory compliance. Responsible for overseeing the collection, preparation and timely submission of regulatory filings. Will establish operational policies, goals and objectives for Regulatory Affairs and Quality Assurance, assuring compliance with FDA, DEA, OSHA and all other regulatory or legal requirements. Serves as senior company spokesperson for all regulatory and quality issues. Member of management leadership team providing guidance and direction on regulatory and quality assurance issues.

Requires PhD in a life science field with 8 to 10 years of Regulatory Affairs experience in the pharmaceutical industry including 4 years of supervisory experience. Experience in biological products as well as CBER and CDER highly preferred. Prior direct liaison experience with the FDA is required. Must be current in FDA regulations, policies and practices for drugs and biological products and be able to develop regulatory strategies that facilitate accomplishment of company goals. Must have well developed influencing and interpersonal skills and strong oral and written communication skills.