Boston, MA

R & D Sr. Regulatory Affairs Manager

Job Title: Research and Development Regulatory Affairs Manager

Department: Research and Development

Job Band: 1C

Reports To: Vice President - Research and Development

FLSA Status: Exempt

SUMMARY

The Manager, Regulatory Affairs is responsible for ensuring compliance with regulations and maintaining accurate labeling for all products. This individual must have expertise in interpreting regulations and applying company policies to meet regulatory requirements in the United States.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Ensure compliance with laws and regulations in all countries where products are sold by verifying ingredients, formulas, labels, and packaging.
  • Collaborate with the graphic design and packaging project management team to execute labeling initiatives.
  • Solve strategic and tactical regulatory issues related to food labeling.
  • Review and approve changes to existing raw materials.
  • Conduct impact assessment of key guidance documents and regulations.
  • Maintain regulatory files and databases in an organized manner.
  • Represent regulatory affairs on internal project teams.
  • Manage the regulatory approval process for new products.
  • Build and maintain specification databases.
  • Interact with external organizations to ensure compliance with criteria such as Kosher, Halal, California Prop-65, and Non-GM.
  • Engage with external trade associations and professional organizations on regulatory and legislative issues.
  • Collaborate with Marketing and R&D on New Product Development to ensure compliance and competitive advantage.
  • Update and manage regulated domestic and international technical product information within internal PLM database.
  • Promote and maintain a culture of safety and a safe work environment.

FOOD SAFETY RESPONSIBILITIES

The job is responsible for ensuring label content, including allergens.

SUPERVISORY RESPONSIBILITIES

This position directly supervises two employees in the Research and Development department. Responsibilities include interviewing, hiring, training, assigning work, appraising performance, rewarding and disciplining employees, and resolving problems in accordance with the organization's policies and applicable laws.

ESSENTIAL QUALIFICATIONS

  • Ability to research regulatory issues and lead/influence resolution.
  • Ability to be persuasive, assertive, and collaborative.
  • Ability to set priorities, meet deadlines, and accomplish team objectives.
  • Ability to manage multiple tasks simultaneously.
  • Ability to work with all levels of management.
  • Exceptional attention to detail and organizational skills.
  • Dependable and able to work well under pressure.
  • Self-motivated and capable of working independently.

Education and/or Experience

B.S. in Food Science (or related field), Masters preferred or prior experience. Ideal candidate should have 5 years of food labeling experience. Export experience is a plus.

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