Sr. Regulatory Affairs Manager Americas

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 $123372.51- $125000. 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 Youll 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 Youll Need:

Education:

• A Bachelors 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.

AAP/EEO 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/veteranstatusor other characteristics protected by law. AAP EEO Drug-Free Workplace.

Other Duties:

Pleasenotethis job description is not designed to cover orcontaina comprehensive listing of activities duties or responsibilities that arerequired ofthe employee for this job. Duties responsibilities and activities may change at any time with or without notice.