Regulatory Affairs Lead, USA

Position Summary

The Regulatory Affairs Lead supports the Regulatory Information Management System (RIMS) for the Huber Agriculture Solutions (HAS) business unit and external customer systems.  This position provides expertise for regulatory affairs projects supporting business maintenance and / or growth and right to operate (RTO)

Monitor & communicate changes in Product Regulations and Standards as identified in the RA Plan. These regulations/standards include, but not limited to:

• Fertilizers
• Adjuvants
• Pesticides
• Biostimulants
• Organic
• Labeling
• GHS

Principal Duties & Responsibilities

• Protect RTO by supporting compliance activities for HAS business including registration renewals, license renewals, and tonnage/mill tax reporting.
• Review labels and SDS’s for consistency and regulatory compliance. Coordinate and support the preparation of North American submissions (dossiers, registrations, actions, etc.) for government and standards agencies (EPA, PMRA, CFIA, state agencies, etc.)
• Utilize inputs from SMEs (Subject Matter Expert), RA team, 3rd parties to:
• Develop guidance and strategies to HAS on behalf of Regulatory Affairs.
• Provide responses for Internal and External Regulatory requests.
• Serve as Regulatory Expert and representative for assigned products and platforms.
• Identify, develop, conduct and/or facilitate regional Regulatory training on Regulatory subjects as identified by management for HAS functional groups and product SMEs.
• Support RIMS system, including Document Analysis and regulatory data management 
• Create and Update policies, procedures, and associated documents on behalf of Regulatory Affairs
• Develop strong relationship with Regional Regulatory SMEs to enhance communication and collaboration.
• Develop strong relationships with the Business to enhance communication and build stronger project teams.
• Provide regulatory support on global projects as needed.
• Domestic travel (<25%) in US (site visits, business meetings, training)

Specialized/Technical Knowledge or Required Skills

• B.Sc. degree or equivalent in Chemistry, Toxicology, Regulatory Affairs, Legal or another science or compliance related field
• 5 years of experience in Regulatory Affairs related to agriculture, agrochemical, fertilizer, and / or industrial products
• Knowledgeable on regulation and the regulatory process
• Experience with project management and process optimization tools desired
• Excellent communication skills (written and oral)
• Well-structured/-organized, capable of working independently and persistently, good collaboration skills, analytical skills
• Good knowledge of Microsoft Office programs, Excel, SharePoint, ERP
• Good understanding of IT applications and databases
• Demonstrated ability to effectively prioritize multiple accountabilities
• Demonstrated ability to identify and elevate Risk and RTO compliance issues
• Effective use of RIMS to plan and communicate with business and external partners
• Effective communication of Regulatory landscape and challenges to business teams
• Results oriented focus to identify and elevate risks/RTOs
• Develops and leverages cooperative relationships across functions/regions to address complex business issues
• Fosters development by expressing expectations, giving feedback, coaching, mentoring, sponsoring, and arranging developmental experiences
• Influences others in efforts to improve Regulatory Affairs performance