Senior Manager, Regulatory Affairs – Americas

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

Benefits offered by this job

Travel up to 5%

Part-time telecommuting option

Job summary

Roquette is seeking a Senior Manager of Regulatory Affairs - Americas in Geneva, IL. You will analyze regulatory requirements for food ingredients, animal feed and industrial products across the Americas and prepare regulatory submissions to U.S. and Canadian authorities.

You will lead GRAS processes, develop label claims, maintain SOPs, and collaborate with Quality, Legal, and Government Relations. Domestic travel up to 5% is required in this role.

Qualifications

• Bachelor's degree or foreign equivalent in Pharmaceutical Science or lifesciences or related field.
• 4 years of experience in regulatory affairs for food, pharma, or related industry.
• Experience with regulatory policies and writing technical dossiers is preferred.

Responsibilities

• Analyze regulatory requirements for US and Canada across multiple GBUs.
• Prepare and publish regulatory submissions and maintain agency files.
• Develop and update regulatory guidelines, SOPs, and internal policies.
• Lead GRAS affirmation processes and advise on label claims.
• Collaborate with Quality, Applications, Legal and Government Relations; travel up to 5%.

Skills

Regulatory affairs

Regulatory submissions

Presentation skills

Compliance monitoring

Cross-functional collaboration

Education

Bachelor's degree in Pharmaceutical Science

Tools

Microsoft Office

Job description

Roquette is seeking a Senior Manager of Regulatory Affairs - Americas in Geneva, IL. You will analyze regulatory requirements for food ingredients, animal feed and industrial products across the Americas and prepare regulatory submissions to U.S. and Canadian authorities.

You will lead GRAS processes, develop label claims, maintain SOPs, and collaborate with Quality, Legal, and Government Relations. Domestic travel up to 5% is required in this role.