Summary:

Advise and recommend policies to ensure product compliance with Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Association (OSHA), Consumer Products Safety Commission (CPSC), Federal Trade Commission (FTC) and other regulations including policy, procedures, documentation, record keeping, auditing, analyzing, piloting, and implementing process improvements in RA and mentoring junior Regulatory staff.

 

Essential Duties and Responsibilities:

Duties may vary between specialists.  This list includes all primary duties shared by Managers.

• Behavior: Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day.


• Attendance: Present for work when scheduled is a mandatory function.


• Safety: Compliance with all company safety rules, procedures, and guidelines are essential.


• Meet with concept teams and propose regulatory strategies for product development. Focus on labeling requirements for products regulated by FTC, FDA, EPA, CPSC and OSHA.


• Monitor and interpret Federal Register CFR, ATTB, EPA, CPSC, OSHA and other sources that provide information on new laws about the Food, Drugs and Cosmetics, Pesticide Products, Institutional Products, Consumer Products industries.  Advise and inform appropriate internal teams on state and federal regulations.


• Assist in review and approval of proposed promotional materials, label artwork as needed, proofs for compliance; ensure compliance with appropriate State and Federal regulations.


• Draft acceptable label copy for use on labeling for drug, cosmetic, pesticide, institutional and consumer products.


• Direct SAP/MDM on label copy version, formula level/revision associations with respect to label assignment validation


• Deviation review and signature as needed.


• Review and approve/reject master boards and artwork in electronic review system.


• Coordinate safety, efficacy, and claims substantiation testing for product development


• Coordinate with R&D to evaluate safety/efficacy implications in waiving testing of products during development.


• Document and file testing results and waivers, notify the organization if issues arise.


• Become familiar with product monographs and regulations to assist in drafting and review of product copy documents.


• Maintain certifications with organizations such as American Dental Association and Kosher Certification.


• Calculate and report tonnage to states that require fertilizer reporting.


• Review and provide Regulatory input on proposed SOPs.


• Gather Regulatory information requested by customers i.e., safety and efficacy testing, claims substantiation, and complete appropriate documentation/surveys for customers in a timely manner.


• Facilitate weekly claims review meetings with R&D, RA, Marketing and Legal.  Scribe and archive substantiation documentation.


• Mentor junior Regulatory staff.


• Attend product development/conversions meetings to assist in developing regulatory strategy.


• Handle other regulatory special projects and job responsibilities as assigned by Regulatory Affairs Director.

 

Supervisory Responsibilities:

In the absence of Director of Regulatory Affairs may be assigned signature authority.

 

Competencies:

A broad knowledge of federal and state environmental, manufacturing, and FDA CGMP regulations and issues desired. 

 

Certificates, Licenses, Registrations:

None

 

Travel:

Limited

 

Work Environment:

Normally exposed to typical office environment.  Occasionally, worker exposed to: Extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort, sufficient noise to cause worker to shout to be heard above the ambient noise level, and hazards such as proximity to moving mechanical parts.

 

Physical Demands:

Occasionally lift boxes of product 5-40 lbs.  Frequently lift samples 1-5 lbs. Walking, talking, hearing, climbing, reaching, grasping, and standing. Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus.