Biotech Regulatory Affairs Manager (Boise, ID)
The J.R. Simplot Company is a diverse, privately held organization, with roots firmly planted in agriculture and agriculture-related businesses.
These endeavors have been around for centuries and will continue to be a vital part of the global economy.
We currently have a Biotech Regulatory Affairs Manager position available in our Plant Sciences Group in Boise, ID.
Boise's mild climate, affordable housing, and vibrant downtown add up to a great place to live and work. SUMMARYThe Biotech Regulatory Affairs Manager will lead efforts for approval of biotech products in the U.S., Canada, Mexico, and other countries as needed for export and trade protection. This position will interface and communicate with U.S. and International Governmental Regulatory agencies to ensure the smoothest path through the regulatory process for Simplot's biotechnology products. The job will require working closely with the Plant Sciences leadership team to plan and execute all studies needed for regulatory approval. The person will hire and manage regulatory consultants who specialize in obtaining approval in each of the countries. In addition, this person collaborates with Quality Systems Manager and Commercial Team for managing successful market launches of biotech potatoes both domestically and internationally. Other responsibilities include collaboration with biotech researchers to influence regulatory agencies regarding the product safety with the goal of minimizing time and resources needed for approval. RESPONSIBILITIES * Communicate and coordinate with U.S. and International Regulatory agencies to foster the optimal path to market and product stewardship in key geographies. Lead efforts to influence regulatory agencies to require only the appropriate studies needed to assess the safety of Simplot's technology.* Work closely with Plant Sciences leadership to execute a regulatory strategy that supports the development timelines and desire to fill the pipeline with new products.* Complete the regulatory approval process for Simplot's biotech product lines. Approval requires submissions to the U. S. Dept. of Agriculture, Environmental Protection Agency, and Food and Drug Administration. Will simultaneously pursue approval with International Governments including Canada, Mexico, Japan, and in other important trade markets. Such approvals will be a continuous process as the development pipeline fills with products demanded by the market.* Integrate scientific, business, intellectual property, and regulatory ideas to drive the approval process. In addition, this person should be motivated to work collaboratively with others and have a proven record of completing assignments.* Provide leadership to teams creating the information needed for regulatory submissions. Acts as one of the principal authors and editors of the dossiers. Lead team completing agronomy studies for the environmental risk assessment and food safety studies. This includes planning regulatory field trials, analytical testing, statistical analysis, completing final reports, and writing dossiers. Collaborate with Regulatory Molecular Biology and R&D teams to obtain information needed for dossiers. Provide oversight to regulatory consultants. REQUIREMENTS* Bachelor's Degree from 4 year college or university required. Master's degree or PhD preferred. * 5-10 years related experience and/or training. Require 5 years relevant experience in the industry, with at least 2 yrs in biotechnology regulatory role. * Strong writing skills required. * 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. * Essential requirements include a background in biological sciences with enough technical depth to understand and explain dossiers to regulatory agencies. This would include 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.* Combination of education, training and/or experience will be considered for this position. HOW TO APPLYExternal Candidates:Visit www.simplot.com/careersSelect Job SearchSelect Current OpportunitiesSelect All Open PositionsApply to Job ID #3738Please prepare a cover letter outlining your interest and qualifications and submit with your resume via our online application process described above.
For best results, please upload your resume as a Microsoft Word or Adobe PDF document.
This process includes additional job-relevant questions, so plan on at least 20 minutes when you apply. When a position is in the interview stage or has been filled, it will no longer appear on our Simplot Careers website.
If you experience any technical difficulties when applying through our online system, please contact our Employment Center for assistance at email@example.com. **The J.R. Simplot Company is proud to be an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, age, sex, gender, gender identity, gender expression, genetic information, physical or mental disability, medical condition, sexual orientation, military or veteran status, marital status, or any other protected status.**