Roquette

Roquette

Sr. Regulatory Affairs Manager - Americas

Geneva (USA) · Senior · Part-time

Sponsorship not specifiedDetected 20 days ago
PharmacologyFDA RegulatoryCollaborationMicrosoft OfficeRegulatory Affairs

About the role

  • We are looking for our next Senior Manager of Regulatory Affairs - Americas.
  • The current salary range for this role is estimated to be $ 123,372.51- $125,000.

Responsibilities

  • 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.
  • Ability to write technical reports and dossiers, including building scientific arguments to support new food and feed products.
  • 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.
  • 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.

Requirements

  • 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.
  • Must be proficient with Microsoft Office suite, including PowerPoint, Word, Excel.
  • Please note this 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.
  • Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences.
  • The required experience must include the following:
  • Domestic and international travel required up to 5% of time.
  • 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.

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.

Benefits

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

Company info

  • 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.

Equal opportunity

  • 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.
  • AAP/EEO Statement:
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This listing is sourced directly from Roquette's careers page and normalized into a canonical job model.