Regulatory Manager - Sumitomo Biorational Company

Sumitomo Biorational Company; Libertyville (IL); On-site; USD 112,000 - 137,000; Full time

Benefits offered by this job

Healthcare on day one

401(k) with matching

Discretionary bonus

Vesting of retirement contributions

Paid time off

Flexible work arrangements

Job summary

Sumitomo Biorational Company seeks an experienced Regulatory Affairs professional to lead global registrations and registrations strategy. You will coordinate data packages, manage master dossiers, and drive submissions for products across regions.

Responsibilities include advising on regulatory strategy, preparing data submissions, and collaborating with internal teams to ensure timely approvals and compliance with EPA, FDA, APHIS requirements.

Qualifications

• 10+ years regulatory experience with a BS in biological/agricultural/chemical sciences.
• 5+ years with an MS/PhD; MBA or related business experience beneficial.
• Knowledge of regulatory policies related to bioprocessing and GMOs.

Responsibilities

• Refine regulatory strategies to align with business goals.
• Develop and communicate strategies for registrations in target countries with timelines and costs.
• Coordinate data packages and submissions for registrations and re-registrations.
• Lead APHIS-related submissions and liaise with regulatory agencies.

Skills

Regulatory strategy

Dossier management

Registration submissions

APHIS liaison

Education

BS in biological/agricultural/chemical sciences

MS/PhD in a related field

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

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.

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:

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.

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.

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