Job Title: Senior Global Regulatory Affairs Manager, Oilseeds
Location: - (Calgary, Alberta, Western Canada, Canada)
Company: Bayer CropScience
Job Type: Full Time
Minimum Years Experience Required: 7
Salary: TBD
Description:
Bayer CropScience is a world leader providing growers with innovative products and solutions for agriculture and environmental health. Growers depend on Bayer CropScience’s comprehensive selection of insecticides, fungicides, herbicides and seed systems. At Bayer CropScience, our team’s commitment and dedication to Canadian agriculture is second to none.
We provide a work environment where you will be working with the best people in the industry. Our goal is to provide interesting and challenging work while at the same time have fun and celebrate successes. We have an immediate permanent full-time opening for a:
Senior Global Regulatory Affairs Manager, Oilseeds
Located in Canada and reporting to the Global Regulatory Team Manager, you will lead the establishment of regulatory studies, creation of regulatory documents and development of regulatory strategy to achieve regulatory clearances worldwide in the shortest time possible consistently with overall business objectives of Seeds.
Responsibilities:
Developing the registration strategy, including data requirements, costs and time-schedules, necessary to achieve global product approvals as required by the project plan in a timely and cost-effective way
Acting as the designated key interface between Portfolio Management and Development functions to provide strategic direction and align the respective needs and overcome limitations
Developing and maintaining the global core dossier for the identified product(s) and, support the Local Registration Managers in adapting it as may be required locally to obtain desired permits and authorizations ensuring the provision of robust scientific information to support key internal regulatory project milestones
Serving as world-wide technical expert on relevant regulatory issues potentially impacting the identified product, defending BCS approach at local, regional or international forums where science-based harmonized approaches may be influenced and promoted and supporting regional and local Registration Managers in responding to government authorities
Participating in designated Crop Life International project teams
Proposing, in line with the business timelines, 1-5 year regulatory studies and activities budget, specifying quality standards to be met, contributing to the creation and updating of robust Project Plans
Evaluating new safety information (publicly derived or privately derived) potentially impacting product approvals and propose response plans
Support regional and local Registration Managers in responding to government authorities.
Providing leadership to a cross-functional team responsible for the implementation, monitoring and continuous improvement of quality assurance and Quality Management Systems for the Global Canola business
Provide technical and regulatory expertise in the drafting and review of commercial agreements with third parties and negotiate the best terms and conditions favourable to Regulatory Affairs and all of Bayer CropScience.
Travel internationally and domestically, as needed, approximately 25%.
Qualifications:
Ph.D. in Agriculture, CropScience or related area, or equivalent experience
7-10 years regulatory experience pertinent to any of several areas directly relevant to GM product safety
Excellent understanding of Seeds & Traits regulatory affairs.
Recognized expertise and proven ability to resolve complicated technical and political regulatory matters.
Very strong organization, planning and budget tracking abilities
Proven leadership skills, including ability to unite diverse groups to a common task and strategy; excellent communication skills to collaborate with diverse internal and external audiences
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