Regulatory Manager - Sumitomo Biorational Company

Sumitomo Chemical Group Companies Of America; Libertyville (IL); On-site; USD 112,000 - 137,000; Full time

Benefits offered by this job

Healthcare coverage

401(k) plan

Discretionary bonus

Retirement contributions vesting

Paid time off

Flexible work arrangements

Job summary

Sumitomo Biorational Company seeks a Regulatory Manager to provide strategic regulatory direction for global registrations of biorational products. You will coordinate submissions, manage dossiers, and interact with agencies to support product approvals across markets.

Experience leading submissions and regulatory strategy, plus strong collaboration with R&D, legal, and manufacturing, are essential. Regular full-time on-site in Libertyville, IL, with travel expectations and competitive

Qualifications

• 10+ years of regulatory experience with a BS
• 5+ years with MS or PhD in biological/agricultural/chemical sciences
• MBA or related business experience is beneficial

Responsibilities

• Coordinate and prepare registrations and amendments for global products.
• Lead regulatory strategy discussions with leadership and business units.
• Interface with regulatory agencies (EPA/FDA/APHIS) and internal stakeholders to ensure timely registrations.

Skills

Regulatory strategy

Global registrations

Stakeholder collaboration

Education

BS in biological, agricultural, chemical or related sciences

MS or PhD in relevant sciences

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Regulatory Manager - Sumitomo Biorational Company

Regular Full Time Libertyville, IL, US

About Sumitomo Biorational Company:

Headquartered in Libertyville, Ill., Sumitomo Biorational Company is the Global Center of Excellence for Biorational Innovation, advancing integrated, science-driven solutions in agriculture, public health, forest health, and environmental markets. As a wholly owned subsidiary of Sumitomo Chemical Co., Ltd., Sumitomo Biorational operates through three divisions: AgroSolutions, Environmental Health (MGK), and Public Health & Forest Health, leveraging decades of expertise to drive innovation and sustainability for customers worldwide.

Description of Job:

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.

Regulatory Strategy

• 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.

Registration Management

• 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.

Biotechnology and Subject Matter Expertise

• 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.
• Support Sumitomo Biorational’s Synthetic Biology Initiatives
  • 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.
  • APHIS Permitting
  • 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

Department Responsibilities and Operations

• 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.
• OMRI submissions

Experience and Education:

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

Key Stakeholders:

Research & Development, Marketing / Asset Management, Legal, Manufacturing, Quality, External Partners (e.g., Contract Research Organizations), Industry Associations

Travel:

10%

What We Offer

We recognize that compensation and benefits play a crucial role in your career decisions. That’s why we’re dedicated to equitable pay practices and transparency in how we reward our employees.

Base Salary:

The estimated annual base salary for this position ranges from:

$112,000 to $137,000. Individual pay is based upon location, skills, experience, and other relevant factors.

Incentives:

All full-time employees are eligible for an incentive program or profit-sharing program in addition to their base salary.

• 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

Our Commitment to a Sustainable Future

At Sumitomo Biorational Company, we’re proud to power a sustainable future through our work. Sustainability and corporate social responsibility (CSR) have been at the core of our culture since the beginning. Today, they continue to drive everything we do.

Join us in making a meaningful impact and contributing to a better world.

• Sumitomo Biorational Company is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation and/or identity, national origin, citizenship, immigration status, disabilities, or protected veteran status.