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R & D Regulatory Affairs Manager

  • Boston, MA
  • Direct Hire
  • Job ID: FL160-2690422
 
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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 regulatory compliance and label accuracy for all products. This person should be experienced in interpreting regulations and implementing sound guidance and company policy to comply with applicable regulations in the United States.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
• Assures ingredients, formulas, labels, and packaging are in full compliance with laws and regulations in
countries where they are sold.
• Collaborates with the graphic design and packaging project management team to execute labeling
initiatives.
• Identifies and provides resolution to strategic and tactical regulatory issues pertaining to food labeling.
• Review and approve any changes to existing raw materials.
• Conducts impact assessment of key guidance documents and regulations.
• Maintain regulatory files/databases and chronologies in good order.
• Represent regulatory affairs on internal project teams.
• Manage regulatory approval process for new products.
• Build and maintain specification data bases.
• Interacts with outside organizations to ensure compliance with all set criteria, to include Kosher, Halal, California Prop-65, and Non-GM.
• Engages with external trade associations and other professional organizations regarding regulatory and legislative issues impacting the Company or industry at large.
• Collaborates with Marketing and R&D on New Product Development to provide input on product benefits for achieving compliance and competitive advantage.
• Updates and manages regulated domestic/international technical product information within internal PLM database, including formula and ingredient approvals.
• Commitment to safety begins with management. Managers and frontline supervisors are accountable for creating and maintaining a culture of Safety and assuring a safe work environment.
 
FOOD SAFETY RESPONSIBILITIES
Job is responsible for label content, including allergens.
Research and Development Regulatory Manager
 
SUPERVISORY RESPONSIBILITIES
Directly supervises two employees in the Research and Development. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
 
ESSENTIAL QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to research regulatory issues and lead/influence resolution.
• Ability to be persuasive, assertive while also being collaborative.
• Ability to set priorities, meet deadlines, and accomplish team objective.
• Ability to manage multiple tasks at one time.
• Ability to work with all levels of management.
• Exceptional attention to detail and well organized.
• Dependable, Works 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 food labeling experience.
Export experience is a plus.

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