Scope of the Role:
The Canadian Regulatory Affairs Team is seeking a Regulatory Affairs Manager for a 12-month contract who will work in a team-based environment to obtain and maintain regulatory approvals primarily for Monsanto's chemistry products. The role will encompass the following responsibilities; Chemistry registrations and database management (50%), Chemistry issues management (20%) and Regulatory guidelines and policy development (30%).
The successful candidate will work closely with colleagues in Regulatory Affairs, Technology Development, Legal, Crop Teams and U.S. Chemistry organizations to develop and implement strategies to gain regulatory approval of Canadian chemistry products. This position will collaborate on the design and conduct of chemical regulatory studies and will prepare necessary documents to obtain and support registration of chemistry products and the establishment, as needed, of maximum residue limits in Canada and in key importing countries.
Key Business Responsibilities:
· Collaborate with colleagues in the Regulatory organization to support global regulatory strategies;
· Develop and manage project plans and coordinate regulatory studies in Canada, evaluate U.S. datasets to obtain the necessary regulatory approvals;
· Participate in defining and developing concepts for new chemistry products to support the Canadian business and setting criteria for acceptable ingredients for new formulations;
· Work with internal groups to develop, maintain and implement product labeling;
· Prepare regulatory submission packages that may include study reports, data summaries, proposed product labeling, product specifications and rationales for approval;
· Respond to questions from customers and regulatory authorities; and collaborate with the business teams on the identification and management of regulatory and stewardship issues.
· Further responsibilities would include implementing new PCPA requirements such as sales, safety and incident reporting as well as portfolio support for product renewals, Category C submissions and discontinuation.
Core Business/Functional Skills and Education:
· An advanced degree (M.Sc./Ph.D) in chemistry or a related discipline is preferred.
· Minimum 3 years working experience as a Regulatory Manager with responsibility for plant pest control product registrations including experience working with the Canada PMRA and knowledge of regulatory processes for pesticide registrations under PCPA is a must.
· Strong communication and interpersonal skills to work effectively in a team-based, matrix-management environment.
· Additional knowledge and experience with Canada fertilizer regulations, generic pesticide active ingredient and end-use product registrations, and/or working with international pesticide regulatory agencies, would all be considered an asset.