Job Title: Regulatory Affairs Director
Location: Boise, ID
Company: J.R. Simplot Company
The J.R. Simplot Company is looking for a a Regulatory Affairs Director for its Boise, ID headquarters.
• Develop and implement a regulatory strategy, in addition to lead efforts for approval of biotech products in the U.S., Canada, Mexico, Japan and other countries as needed for export and trade protection
• Interface and communicate with U.S. and International Governmental Regulatory agencies to ensure the smoothest path through regulatory for Simplot and Simplot partner biotechnology products
• Work closely with the R&D director and other Research Scientists to plan and execute all studies needed for regulatory approval
• Hire and manage regulatory consultants who specialize in obtaining approval in each of the countries
• Develop and oversee quality systems for managing successful market launches of biotech potatoes both domestically and internationally
• Collaborate with biotech researchers to influence regulatory agencies regarding the product safety with the goal of minimizing time and resources needed for approval
• 10 years related experience and/or training
• 5 years of practical experience in the field of plant biotechnology
• Requires 10 years relevant experience in the industry, with at least 5 yrs in biotechnology regulatory role
• Background in quality systems, project management, statistics, potato growing practices, plant biology, government regulations, and food processing desired
• Experience working for National level regulatory agencies desired
• Knowledge and experience in molecular biology is required, and knowledge of plant physiology and/or genetics is desirable
• Experience in the area of biotechnology is also desirable
• A proven track record of developing dossiers for approval of biotech plants by US and International agencies would be ideal
• A background in biological sciences with enough technical depth to understand and explain dossiers to regulatory agencies
• Strong verbal and written communication skills and a practical understanding of U.S. and International regulations for biotech products
• Knowledge and use of negotiation skills through executed agreements and collaborative research
• Candidates must excel at working collaboratively with other groups at Simplot and with external colleagues and partners
• This individual must be a self-starter, willing to work with minimal direction
• 25% travel required
• B.S. (M.S. or PhD preferred) in the Sciences, which could be from Molecular Biology, Biochemistry, Genetics, Plant Physiology, Engineering, or other relevant majors
• The ideal candidate would have an advanced degree and at least 10 years relevant industry experience, including 5 years in biotech regulatory
To apply, please send your MS Word resume along with salary requirements to:
An equal opportunity employer, m/f/d/v.
Please reference BioTechPharmJobs.com when responding.
degree programs are an option for people who realize that the job they
want requires advanced education.