Global Regulatory Manager – Biotech & Agro Solutions

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

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.