Senior Manager Regulatory Affairs

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 a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients.

Want to help us make a difference?

Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients.

Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles.

The Role:

We are looking for our next Senior Manager of Regulatory Affairs - Americas.

This position is located in Geneva, IL.

Compensation:

The current salary range for this role is estimated to be $123,372.51- $125,000. In addition, this position may also be eligible to earn performance-based incentive compensation. The specific compensation offered to a candidate will be influenced by a variety of factors including but not limited to skills, qualifications, experience, and location.

What You'll Do:

Analyze and interpret regulatory requirements applicable to food ingredients, animal feed, and industrial product lines across all Global Business Units (GBUs) of Roquette, covering United States and Canada markets. Prepare and publish regulatory submissions and supporting documentation for internal stakeholders and federal agencies to ensure compliance with applicable regulations. Draft, maintain, and update regulatory guidelines, departmental positions, and standard operating procedures (SOPs) while maintaining regulatory agency files in inspection-ready condition to ensure compliance readiness. Support Regulatory Head on complex regulatory problems requiring in-depth evaluation of situations, data, and various contributing factors. Provide monitoring and analytical support to ensure internal compliance with regulatory policies and effectively communicate regulatory information to all organizational levels using strong presentation skills.

Develop regulatory strategies in collaboration with designated teams to register novel ingredients and components for Roquette food and feed products, and assist in food product qualification processes with various regulatory agencies to ensure regulatory frameworks are properly translated into regulatory policies and implemented. Create and update regulatory systems and documentation for product and agency compliance based on current and emerging legislation, and implement tools and databases for regulatory operations and process improvements. Provide regulatory assessments and support for daily customer compliance requests, compile product ingredient information and regulatory assessments by country for the Americas and globally, and provide regulatory documents for food and feed products in compliance with customer and country-specific requirements.

Lead Generally Recognized as Safe (GRAS) affirmation processes and develop food product label claims, including Natural, GMO, and Organic product strategies in accordance with developing legislation. Influence development of new regulations and updates to existing regulations through collaboration with health authorities and trade associations to prepare the regulatory landscape for future innovations. Serve as regulatory interface between Quality, Application groups, Scientific, Legal, and Government Relations departments, and communicate internally and externally with colleagues, regulatory contacts, suppliers, and customers regarding product support and compliance matters. Solve complex regulatory problems and efficiently interact with colleagues, managers, and regulatory agency representatives. Domestic and international travel required up to 5% of time. Part-time telecommuting within the area of intended employment is permitted.

What You'll Need:

Education:

A Bachelor’s degree or foreign equivalent in Pharmaceutical Science or other Lifesciences or related field, plus 4 years of experience in a regulatory affairs occupation with a food ingredient, or pharma ingredient, or consumer packaged food company.

Experience:

The required experience must include the following:

• 4 years of experience in regulatory or quality compliance for food ingredients;
• 4 years of experience in technical aspects of food or pharmaceuticals such as chemistry, pharmacology, nutrition, or similar technical activities,
• 2 years of experience with food regulations and policy environment.

Any and all experience may be gained concurrently.

Demonstrated Knowledge:

• Ability to write technical reports and dossiers, including building scientific arguments to support new food and feed products.
• Must be proficient with Microsoft Office suite, including PowerPoint, Word, Excel.
• Chemistry as applied to the manufacturing processes of food or pharma products.

*Demonstrated knowledge may be obtained through education, training or experience.

Equal Opportunity Statement:

Roquette is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. AAP, EEO, Drug-Free Workplace.

Other Duties:

Pleasenotethis job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.