Senior Manager, Regulatory Affairs — Americas Strategy

Wayne State University; Geneva (IL); On-site; USD 123,372 - 125,000; Full time

Job summary

Roquette is seeking a Senior Manager of Regulatory Affairs - Americas in Geneva, IL. This role leads regulatory strategy and submissions for US and Canada, ensuring compliance across food ingredients, animal feed, and industrial products.

You will develop and maintain SOPs, interact with Regulatory Head and cross-functional teams, and oversee GRAS processes, labeling strategies, and regulatory communications. Some travel is required.

Qualifications

• Bachelor’s degree or foreign equivalent in Pharmaceutical Science or related Lifesciences.
• 4 years of experience in regulatory affairs in food, pharma, or consumer goods.
• Experience with regulatory policy and submission processes.

Responsibilities

• Analyze regulatory requirements for US/Canada markets across GBUs and prepare submissions.
• Draft and maintain SOPs, regulatory guidelines, and agency files for inspection readiness.
• Develop regulatory strategies to register novel ingredients and support compliance requests.
• Lead GRAS affirmation processes and coordinate label claims compliant with regs.

Skills

Regulatory affairs

Regulatory compliance

Microsoft Office

Presentation skills

Education

Bachelor's degree in Pharmaceutical Science or related Lifesciences

Tools

Microsoft Office (PowerPoint, Word, Excel)

Job description

Roquette is seeking a Senior Manager of Regulatory Affairs - Americas in Geneva, IL. This role leads regulatory strategy and submissions for US and Canada, ensuring compliance across food ingredients, animal feed, and industrial products.

You will develop and maintain SOPs, interact with Regulatory Head and cross-functional teams, and oversee GRAS processes, labeling strategies, and regulatory communications. Some travel is required.