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Manager, Regulatory Affairs- Combination Products

Lake Forest, Illinois

Post Date: 07/25/2017 Job ID: 1404 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 for a Manager, Regulatory Affairs supporting our clients robust Combination Products portfolio in Lake Forest, Illinois. Join us and propel your career in a global setting. 

In a key and highly visible role, this individual will act as the regulatory core team member for, and provide regulatory guidance to combination product project teams in a fast paced, highly visible, complex, and at times ambiguous and changeable environment.

Job Responsibilities:
  • Responsible for the creation of all submission documentation for a project with a large portfolio of products.  This includes correspondence, meeting requests and dossier content, including labeling 
  • Set and communicate timelines for the regulatory submissions and for the delivery of supporting documentation.  Must work with all functional areas to obtain needed information on time    
  • Anticipate the impact of potential team decisions on the regulatory strategy, timelines, project goals, and other programs and influence the team as needed.  
  • Review scientific information to ensure the data is complete, sound, logical, and supports the program goals.  Must be able to work with authors to ensure supporting information is clearly and logically written, in order to ensure it is submission ready  
  • Exquisite attention to detail is required to ensure alignment both within and between dossiers for large portfolio projects, both the incumbent’ s and those of colleagues 
  • Able to handle multiple projects of various complexities (very simple to very complex) simultaneously and meet the project goals 
  • May provide guidance to others on the creation of labeling or dossier contents.  May approve labeling. 
  • Interact and effectively negotiate with regulatory authorities 
  • Maintain awareness of applicable regulations and guidances and informs project teams of new information, along with its possible impact to the project, as appropriate. 
    Interprets regulations and ensures regulatory compliance 
  • Exercises good judgment within company policy and health authority regulations.

Qualifications/ Requirements:
  • Bachelor’ s degree in pharmacy, nursing, biology, chemistry, pharmacology, engineering or a related subject is required. Masters is preferred; Ph.D is highly preferred 
  • Minimum 5 years of experience in either pharmaceutical or device regulatory affairs, preferably both. Be able to quickly learn the other discipline if inexperienced.  Must quickly become effective in both disciplines 
  • Excellent written and interpersonal communication skills.  Must be able to present all information (regulatory and scientific) effectively, both orally and in writing, in a concise, logical, and persuasive manner 
  • Understand the intent of the regulations to wisely navigate the discrepancies that exist in the application of each set of regulations to combination products, in order to ensure the decisions work well throughout the lifecycle of the products and to set appropriate precedent for future products and projects 
  • Previous experience with combination product regulatory strategy and/or execution is beneficial

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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