What are the responsibilities and job description for the Regulatory Specialist position at MERCOLA CONSULTING SERVICES?
SUMMARY
The Regulatory Specialist will provide regulatory support to internal team members and external customers regarding all regulatory and legal requirements associated with the labeling and marketing of consumer products distributed by Natural Health Partners. This position provides insight to help determine company decisions associated with Food and Dietary Supplement labeling regulations and new product launches based on extensive knowledge of Federal Regulations.
KEY RESPONSIBILITIES & DUTIES
- Collaborate with cross functional teams including Marketing, R&D, Quality Assurance, Product Supply, and Product Safety to launch new products and support current marketed products.
- Ensure FDA compliance with dietary supplements, food, and cosmetic labels including calculating and confirming nutrition/supplement values, allergen and ingredient lists, net weight statements, nutritional and advertising claims, and standards of identity.
- Review finished product documentation including tentative specs, nutritional profiles, ingredient statements, etc.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Conduct research of International, Federal, State, local, and internal regulatory requirements.
- Develop and provide regulatory strategies, regulatory assessments, and options analysis for projects.
- Maintain working knowledge and understanding of existing and emerging food and dietary supplement regulations.
- Monitor the regulatory environment for changes in regulatory requirements related to supplements, food, and other product classifications and effectively communicate these changes to applicable parties. Support any follow-up actions to ensure compliance with new requirements.
- Assist with obtaining and/or renewing relevant national certifications.
- Assist with the review of product claims made in marketing and sales collateral, websites, and other consumer communications for compliance with applicable regulations and guidelines.
- Communicate with teams to ensure all regulatory procedures are understood and train team as needed.
- Work closely with the Senior Quality Assurance Manager and Product Development team to ensure compliance.
- Simultaneously manage multiple deadlines and projects.
- Identify gaps and inefficiencies in regulatory procedures and provide solutions to improve.
- Other duties as assigned.
REQUIREMENTS/QUALIFICATIONS
- Education: Bachelor’s degree in Regulatory Affairs, Food Science, Food Technology, Nutrition, or related field preferred.
- Experience: 2 years of regulatory experience preferred.
- Skills:
- Strong interpersonal and communication skills.
- Strong organizational skills and ability to multitask.
- Sound judgment and critical thinking to resolve challenges.
- Attention to detail, accuracy, and commitment to timeliness.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
PHYSICAL DEMANDS
- Prolonged periods of sitting at a desk and working on a computer are required.
- Frequent use of hands for typing, handling documents, and operating office equipment.
- Ability to read, analyze, and interpret detailed regulatory documents, reports, and computer screens.
- Regularly required to talk or hear in person and via electronic communication tools.
- Occasionally required to stand, walk, and reach with hands and arms during office activities or when accessing files and records.
- May occasionally need to lift and/or move up to 20 pounds.
