Regulatory Compliance Specialist

Job Description

Job Description

Summary : A Specialist, Regulatory & Compliance is responsible for ensuring that all products are manufactured, packaged, and labeled in compliance with strict regulatory requirements. This includes enforcing the FDA's Current Good Manufacturing Practices (cGMP) for dietary supplements, known as 21 CFR Part 111 and 117. The role is responsible for ensuring that products are manufactured, labeled, and marketed in accordance with federal laws, primarily the FDA's Dietary Supplement Health and Education Act (DSHEA)

Duties and Responsibilities:

• Providing an accurate and timely response to customer requests relating to regulatory and compliance requirements as it relates to products manufactured by Dosage Form (DF) (Powder/Capsule/Tablet) operations (i.e. to support new or reformulated product launches, change of ingredients sources, and requests for regulatory documentation).
• Serve as the primary point of contact for site authority inspections or inquiries from regulatory authorities, including Audit Management: FDA facility inspections or third-party certification audits such as USDA Organic or NSF, UL.
• Responsible for acquiring and maintaining all regulatory registrations and notifications vital to obtain authorizations for the applicable activities.
• Responsible for supervising regulatory and compendium changes that impact the DF business and aiding in action plan development for compliance.
• Ensure accurate regulatory assessments of raw materials and formulas are performed.
• Responsible for risk assessment and mitigation activities related to potential product recalls.
• Provide support for raw material qualification, by resolving compliance deliverables for the intended scope such as appropriate regulatory and quality standards, specific compliance declarations such as harmful substances, GMO, gluten, allergens, NSF sport, WADA, Prop 65, etc.
• Provide mentorship on labeling, which includes the development of Supplement Facts panels, in compliance with US FDA regulations.
• Drive efficiencies in current processes to ensure regulatory and compliance aspects are accurately captured.
• Partner with business leaders and Regulatory leadership ensuring all projects are appropriately prioritized, goals are met on time, and commercial/customer support is delivered.

• Lead and participate in initiatives to reduce waste, improve processes, and enhance overall product and service quality

Work Experience/Qualifications:

·         Minimum of 3 years’ relevant work experience in Specialist, Regulatory & Compliance.

·         Proficiency with laboratory testing, data analysis, and quality management software

·         Excellent leadership, communication, and problem-solving skills to effectively manage a team and collaborate with other departments.

Education Requirements:

·         A Bachelor’s degree in a scientific field such as Biology, Chemistry, Food Science, or Nutrition Science is typically required.

Professional credentials like the Regulatory Affairs Certification (RAC) or PCQI (Preventive Controls Qualified Individual) are highly valued

Work Environment: 

·         The work environment characteristics described here represent those an employee encounters while performing this job's essential functions.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·         While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts, fumes, or airborne particles and risk of electrical shock.

·         The noise level in the work environment is usually moderate.

·         While in the plant, the employee must utilize the required personal protective equipment.