Saint-Gobain is the world's largest manufacturer and distributor of building materials, and a leader in the production of high-performance materials and glass containers with more that 1,000 subsidiaries in 64 countries. Saint-Gobain was founded in 1665 and is headquartered in Paris, France. Saint-Gobain had sales of $53.2 billion in 2010 and employs nearly 190,000 people worldwide.
Saint-Gobain Performance Plastics is the world’s leading producer of engineered, high-performance polymer products, serving virtually every major industry across the globe. Saint-Gobain Performance Plastics’ businesses support these key industries in bringing advanced technology polymer products and using them in the most demanding applications. Backed by a proud heritage of product innovation, technological expertise and market leadership, Saint-Gobain Performance Plastics is dedicated to working with its customers to solve today’s application issues and the challenges that lie ahead.
Saint-Gobain Performance Plastics is looking for a North American Regulatory Affairs Manager to work in our Fluid Systems business. The Regulatory Affairs Manager will assist in the development of new products, new markets and new geographics locations for products by providing regulatory (legal) input for the pharmaceutical and medical device industries.
The main responsibility of the Regulatory Affairs Manager is to plan and execute all activities for the registration of new products and product line extension. In addition, the manager ensures that company policies, procedures and operating guildelines are adhered to and that the business conforms to all laws, regulations and industry practices.
Manage and facilitate all registration related activies including completing forms from government agencies; updating licensing and collecting information on registration instructions and regulations.
Develop and maintain a compliance program, including the implementation of QA systems and SOP's in order to deal with quality related questions and or complaints.
Maintain professional contact with regulatory authorities and company headquarters; provide the Project Teams with regulatory input to obtain regulatory approvals as part of product development planning.
Participate as a member of the global Risk Management Team.
Participate in the strategic planning process to provide direction to use competitive advantages more efficiently.
The successful candidate will have a technical degree (Pharmacy preferred), be fluent in English with 5 years experience in a manufacturing environment, dealing with governmental regulations. Experience with a US government contract business is a plus. The candidate will possess excellent verbal and written communication skills, strategy and planning skills, a demonstrated ability to interact effectively with all functional groups within the organization and in the industries served and be able to demonstrate an ability to understand complex problems and present workable solutions.
This position can be located at any of the Performance Plastics Fluid Systems locations. Akron/Aurora, OH; Beaverton, MI; Bridgewater/Mickleton or Wayne, NJ; Postenkill, NY; Taunton, MA; or Portage, WI.