Regulatory Compliance Specialist

About Us:
Premier Research Labs is a dynamic, fast-paced leader in the natural health and nutrition industry with both retail and wholesale divisions. We have a great company culture with a friendly, highly motivated staff that is dedicated to creating premier quality nutritional supplements and natural food products that truly make a difference in people’s lives. Become part of our awesome production team that plays an integral role in the manufacturing of our exceptional products.

Position Summary:
Regulatory Compliance Specialist oversees the Corporate Compliance Program, functioning as an independent and objective body that reviews and evaluates compliance issues/concerns within the organization. The position ensures management and employees are in compliance with the rules and regulations of regulatory agencies, that company policies and procedures are being followed, and that behavior in the organization meets the company’s Standards of Conduct. Acts as a link between company and regulatory authorities when needed, ensuring that products are manufactured and distributed in compliance with appropriate regulations.

Essential Functions
  • Develops, initiates, maintains, and revises policies and procedures for the general operation of the Compliance Program and its related activities to prevent illegal, unethical, or improper conduct. Manages day-to-day operation of the Program.
  • Collaborates with other departments (e.g., Risk Management, Internal Audit, Employee Services, etc.) to direct compliance issues to appropriate existing channels for investigation and resolution.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, vendors and management.
  • Monitors, and as necessary, coordinates compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends.
  • Identifies potential areas of compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.
  • Evaluates product promotional materials, labeling, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Performs scientific and legal documents review, and toxicology evaluations as needed.
  • Analyze complicated information, including trial data if appropriate.
  • Maintains all regulatory compliance local, state, and federal documentation and registrations with regulatory bodies.
  • Advises project teams on subjects such as regulatory requirements, and labeling requirements.
  • Writes comprehensible, user-friendly, standard operating procedures (SOPs) that are compliant with current regulations as needed.
  • Assists with audits and inspections, as required.
  • Other work as assigned.
Education & Experience
  • Bachelor’s degree in related field, or equivalent experience
  • 3-5 years’ experience in similarly regulated industry
  • Previous GMP experience preferred
  • Strong verbal and written communication skills
  • Must have working knowledge of Microsoft office
Core Competencies
  • Problem Solving/ Critical Thinking/ Critical Analysis
  • Understand and translate local and global nutraceutical regulations
Work Environment
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is in an office environment and routinely uses standard office equipment. This position involves sitting for extended periods of time.
Work Schedule
  • Monday-Friday, 8:00am-5:00pm (shifts may vary based on needs of the company)
  • Occasional overtime may be required
  • No travel required
Employee Benefits:
PRL is committed to help support employees by offering company benefits.
  • Paid Time Off
  • Competitive Compensation
  • Paid Holidays
  • Healthcare insurance
  • Dental and Vision insurance
  • Life Insurance
  • 401(K) retirement program with company match
  • HSA (Healthcare spending or reimbursement account)
  • Employee product discounts
  • A great company culture with a teamwork attitude
  • Excellent managers who really care about their staff