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Manager, Regulatory Affairs Charlottesville United States,  

Perrigo (company)

Posted on : 11 July 2017

Project Description

Job Description 
Manage regulatory activities that support development of new and maintenance of existing commercialized products in Consumer Healthcare, Nutritional Foods, and Liquids.     
  • Collaborate with the project team to develop regulatory strategy, milestones and submission deliverables for the development of new adult and toddler nutritional products.  
  • Execute regulatory activities per the project plan to assure new products meet submission, approval and commercial launch goals.  
  • Support manufacturing and procurement in the management of change to existing commercial products.  
  • Maintain product labeling in compliance with laws and regulations.  
  • Negotiate directly with FDA and other health authorities to resolve regulatory issues.  
  • Coach and develop junior staff members to become proficient in regulatory decision making.   

Required Experience 
  • Must possess excellent analytical skills and the ability to apply policies and general regulations to specific products or projects. 
  • Good verbal and written communication skills are necessary.  Demonstrated leadership skills are required. 
  •  The ability to work effectively on project teams is required.  Knowledge of scientific, regulatory and trade dress terminology is necessary.  
  • These skills are normally acquired through possession of a bachelor degree in a health sciences field such as biochemistry, chemistry, pharmacy or pharmacology, combined with a minimum of 3 years of experience in the nutrition or regulatory. Bachelor degree in a health care related science (e.g. biochemistry, chemistry, pharmacy, pharmacology) required.  Masters or Ph.D. preferred. 


Charlottesville Virginia United States

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