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Regulatory Affairs Manager

TBD, Utah
JOB DESCRIPTION
 
Regulatory Affairs Manager
 
Full Time, Salaried, Exempt position in the Regulatory Affairs Department. Will report to Director of  Regulatory and Technical Services  
GENERAL DESCRIPTION: Manage the creation, preparation and achievement of regulatory submissions/approvals in our global markets. Ensure corporate compliance with all regulatory and governmental agency licensing and regulations.
 ESSENTIAL DUTIES/RESPONSIBILITIES/FUNCTIONS: reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Plan, coordinate, and prepare document packages for regulatory submissions.
  • Submit U.S. and international regulatory applications.
  • Maintain submission correspondence files and other regulatory files in a complete and secure manner.
  • Provide project, department, and company guidance on current and emerging regulatory affairs requirements, regulations, and processes, and focus on improved regulatory efficiency and effectiveness.
  • Oversee the creation and revision of product labels and participate in the final label process.
  • Oversee the preparation and distributions of product registration and other regulatory document.
  • Ensure that all intellectual properties are maintained and kept current.
  • Ensure that the company is compliant with all domestic and international regulatory agencies such as the Food and Drug Administration (FDA); Texas Department of State Health Services (TDSHS); REACH; KOSHER; HALAL; and all foreign country regulatory authorities.
  • Schedule Kosher, and Halal inspections and escort the Kosher, and Halal officials during the inspection.
  • Respond to regulatory and technical questions from international offices, Forever Business Owners, and consumers.
  • Ensure compliance of cGMPs, environmental regulations, and health and safety regulations.
MARGIN JOB FUNCTIONS:
  • Develop and approve Company SOPs for the Department.
  • Comply with Company SOPs and policies.
  • Act as Regulatory lead on manufacturing and development teams, providing Regulatory Affairs feedback and guidance on regulatory inputs needed for global submission requirements.
  • Work with Quality Management to develop/maintain regulatory information for Supplier Database.
  • Work with R&D department on regulatory needs for global markets based on proposed product ingredients and formulas.
  • Assist with development/maintenance of spreadsheets and tracking tools for measuring department objectives.
  • Maintain a professional expertise of regulations through regulatory literature, courses, and seminars.
SUPERVISORY RESPONSIBILITIES:
  • This position supervises employees in the department, and is responsible for the performance management and hiring of employees within the department.
  • Execute performance management to include planning, monitoring, reviewing and evaluating performance of personnel.
  • Provide training, constructive feedback, and conduct performance reviews to direct reports.
  • Enforce company policies.
COMPETENCIES:
  • collaboration skills                                                               
  • Communication proficiency
  • Control process                                                               
  • Customer/client focus
  • Decision making
  • Ethical conduct
  • Forming judgement
  • Interpersonal skills
  • Managing organizational skills
  • Performance management
  • Personal effectiveness/credibility
  • Problem solving/analysis
  • Stress management
  • Verbal/written expression
QUALIFICATIONS & SKILLS REQUIRED TO PERFORM JOB DUTIES:
  • Knowledge of 21 CFR Good Manufacturing Practices.
  • Knowledge of food and cosmetic labeling requirements such as HACCP regulations, and international regulations (the European Commission Directives such as Cosmetics Directive, REACH, Novel Foods, Nutrition labeling for Foodstuffs, and the Food Supplements Directive).
  • Knowledge of Regulatory Affairs, experience in Quality Assurance and Document Control.
  • Proficient in Microsoft Office.
  • Demonstrate organizational skills, strong verbal and written communication skills, and attention to detail.
  • Strong proofreading skills.
  • Must possess good interpersonal, communication (oral and written), organizational, and project planning skills.
 EDUCATION AND/OR EXPERIENCE REQUIRED TO PERFORM JOB DUTIES:
  • Bachelors and/or Master’s degree in scientific or technical field from an accredited college, or equivalent combination of education and experience.
  • Minimum 5 years of experience in food, cosmetics, or related industry with experience creating and reviewing FDA-compliant labeling, working with R&D and vendors to create FDA-compliant formulas, and conducting quality and GMP audits.
  • RAPS, ASQ, HACCP or other industry-related certification a plus.
 
Thank you for considering this opportunity!
 
 

 
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