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Associate Director, Regulatory Affairs

Lake Forest, Illinois

Post Date: 06/05/2017 Job ID: 1403 Job Category: Clinical: Regulatory

Our Client is a leading provider of infusion technologies. The company' s focused infusion systems portfolio features I.V. solutions, proven, innovative smart pumps, and pain management and safety software technology designed to help meet clinical, safety and workflow goals. 

We have an exciting opening in our Global Regulatory Organization for an Associate Director, Regulatory Affairs. In a highly visible and strategic role, the incumbent will lead the oversight for the US based team that supports global pharmaceutical marketed product portfolio from launch through market withdrawal globally. S/he will develop and implement global regulatory strategies to maintain existing registrations in compliance with applicable global regulations. As a key member of the leadership team, they will provide regulatory consult on Manufacturing Operations initiatives and derive innovative strategies to progress with Global Health Authorities.

Job Responsibilities:
  • Provide global regulatory impact assessment for changes to currently approved products in line with global regulations 
  • Define and implement regulatory strategies and priorities in support of changes to approved products 
  • Advise program/teams on regulatory requirements, coordinates and presents regulatory data needs, and negotiates with and influences management, colleagues and partners to ensure regulatory data requirements are met 
  • Manage the preparation and review of registration packages to ensure effective data presentation and quality 
  • Propose new/revised policies and recommend standard interpretation of global regulations 
  • Maintain an awareness of global legislation and assess its impact on the business and product development programs 
  • Create systems to assure regulatory compliance, and strives to ensure that products remain in compliance 
  • Manage the processes to achieve regulatory agency input 
  • Request, manage and facilitate agency meetings

Qualifications/ Requirements:
  • Ten years experience in the pharmaceutical industry as needed for the position, proprietary and/or biologics product development preferred. 
  • Minimum of five years experience in regulatory affairs, with a focus on biologic and/or proprietary drug development preferred. 
  • Experience working directly with regulatory agencies.   
  • Sound knowledge of applicable portions of global regulatory guidances and regulations. 
  • Excellent communications skills at all levels - both internally and externally. Strong interpersonal skills. Proven negotiating skills.  Strong management skills. 
  • Experience in contract manufacturing, development or other customer service related experience preferred.

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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