Regulatory Manager - Sumitomo Biorational Company

Sumitomo Chemical: Group Companies of the Americas

Libertyville (IL)

On-site

USD 112,000 - 137,000

Full time

6 days ago

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Benefits offered by this job

Health insurance

401(k) matching

Discretionary bonus

Paid time off

Flexible work arrangements

Job summary

Sumitomo Biorational Company in Libertyville, Illinois seeks a Regulatory Affairs Manager to lead global registrations for biorational products. You will coordinate registrations, manage APHIS/EPA/FDA submissions, and guide cross-functional teams to align regulatory strategy with business goals.

The role requires 10+ years of regulatory experience (BS) or 5+ years with MS/PhD, and offers a base salary of $112,000–$137,000 with comprehensive benefits and flexible work arrangements.

Qualifications

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

Responsibilities

Refine regulatory strategies and design new ones based on business goals and external influences.
Develop and communicate strategies for registrations in target countries with timelines and costs.
Coordinate and submit data packages for registrations and re-registrations.
Maintain knowledge of current biorational regulatory policies and decisions.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory forecasting

Strategic advisory

Education

BS in biological/agricultural/chemical sciences

MS/PhD in related sciences

Job description

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.

About Sumitomo Biorational Company

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.

Principal Responsibilities

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.
SDS authorship
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:

$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.

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

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.

#Sumitomo

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