Regulatory Manager - Sumitomo Biorational Company

Sumitomo Chemical Group Companies of America • Libertyville, IL

7h • $112,000 - $137,000 • Hybrid

About The Position

Provide technical expertise, scientific knowledge, business perspective, and strategic direction to the corporation in regulatory matters that pertain to Agriculture, as well as associated applications and businesses. The position is responsible for the coordination, preparation, submission, and attainment of registrations and re-registrations for biorational products to support global registrations and defense to Sumitomo Biorational’s businesses in a manner that reflects appropriate levels of strategic design and implementation.

Requirements

• 10+ years of relevant Regulatory experience with a BS, or 5+ years’ experience with a MS or PhD in biological, agricultural, chemical or associated sciences is required.
• Scientific background in chemistry, toxicology or environmental fate will be highly valued.

Nice To Haves

• An MBA or significant agricultural or biotechnology-related business experience is beneficial.

Responsibilities

• Work with Manager and other corporate leadership personnel to refine current regulatory strategies and/or design new ones based on internal business goals and prevailing external regulatory influences.
• Develop and communicate strategies for obtaining registrations in target countries, including timelines and costs for achievement of registrations in line with business objectives.
• Provide regulatory advice and foresight to the business units and functions, developing and communicating strategies for dealing with potential issues.
• Prepare and submit applications for new product registrations and new uses and other amendments for current product registrations on an international level.
• Coordinate and submit data packages and information in support of the registration and re-registration of active ingredients and end products.
• Management of regulatory dossiers (Master Dossiers) for a series of products based on asset (active) and/or country/region
• Prepare responses to data call-ins and other information requests from regulatory agencies.
• Maintain knowledge of current biorational regulatory policies and decisions, including topics related to production through use of bioprocessing from wild-type and genetically modified organisms.
• Develop a regulatory strategy to support new products with genetic modifications in Ag and non-Ag business sectors in collaboration with Synthetic Biology Manager.
• Lead submissions to respective regulatory agencies (EPA, FDA, APHIS) and implement laboratory testing to support submissions.
• Act as Sumitomo Biorational’s internal APHIS expert; develop relationship with APHIS (PPQ and BRS) officials and serve as a centralized location of APHIS related materials
• Author and submit applications on behalf of researchers but in close collaboration to ensure accuracy and success
• Lead internal APHIS committee that bridges regulatory and research departments
• Execute APHIS related training annually for research staff and to new hires in research
• Participate in project updates and label development
• Stay informed of current regulations to insure and lead company in compliance.
• Participation in peer review of studies to determine possible regulatory implications.
• Provide technical regulatory support to customers.
• Work with in-house legal counsel on general regulatory and compliance issues affecting company.
• Liaise with government agencies regarding regulatory issues.
• SDS authorship
• OMRI submissions

Benefits

• High-quality healthcare coverage starting on day one, with options for medical (HSA/HRA), vision, and dental plans
• 5% company contribution to your 401(k), plus a quarterly discretionary bonus
• Immediate 100% vesting of all retirement contributions
• Financial assistance programs to support your goals
• Life and disability insurance for added security
• Generous paid time off, including vacation, holidays, and volunteer days
• Flexible work arrangements available

What This Job Offers

• Job Type: Full-time
• Career Level: Senior