Sr. Regulatory Affairs Manager

Roquette•Geneva, IL

3d•Onsite

About The Position

Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients. We are looking for our next Senior Manager of Regulatory Affairs (Core Food Business) – North America within our Regulatory Affairs team. The Senior Manager will lead regulatory strategy, develop regulatory dossiers, and ensure compliance across the United States and Canada while enabling business growth in food, animal feed, and plant care markets. This position is located in Geneva, IL.

Requirements

Bachelor’s degree in food science, nutrition, chemistry, pharmacy, or a related technical field.
Minimum of 7 years’ experience in regulatory affairs or quality environments within the food and/or pharmaceutical industry.
Strong knowledge of regulatory frameworks for food ingredients and additives in the United States and Canada, with demonstrated experience leading complex, cross-functional initiatives.

Responsibilities

Organize and lead development of regulatory dossiers to support new products and expanded uses across food ingredients, industrial applications, animal feed, and plant care.
Partner with Quality Assurance to support quality systems, including change controls, raw material and processing aid evaluations, and process improvements.
Review and interpret regulatory requirements applicable to product portfolios across the United States and Canada.
Define and execute efficient, cost-effective regulatory strategies to enable successful market expansion.
Prepare, review, and manage regulatory submissions and communications with regulatory agencies.
Maintain an organized inventory and tracking system of all regulatory submissions.
Provide regulatory assessments and support for customer compliance requests, including drafting regulatory statements.
Implement and enhance tools and databases to drive regulatory operations efficiency.
Monitor evolving regulatory landscapes and proactively advise the organization on changes and impacts.
Represent Roquette in trade associations and ensure alignment with company strategic goals.