Regulatory Specialist

Functions of the Job

This position is responsible for communicating and tracking customer specific and state agency related Regulatory Compliance information for products manufactured at all facilities including contract facilities. The candidate is also responsible for maintaining the Regulatory reporting calendar for submissions.

• 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. Work hours may extend past normal business hours based on the workload of the department.
• Safety: Your compliance and enforcement of all company safety rules, procedures and guidelines is essential. Reporting of safety issues is mandatory.
• Responsible for communication and tracking of key customer compliance information as an extension of Technical Sales. This includes submitting technical information into customer facing portals, and providing teams with customer friendly communications.
• Maintain and track compliance documents from suppliers
• Maintain and track registrations in state agencies with respect to Packaging, Cosmetic, and Environmental regulations. Example include post consumer recycled plastic legislation, Safe Cosmetics, Chemicals of concern for children, Prop 65, California Air Resources Board, etc.
• Review Regulatory Intelligence Sources to provide direction and recommendations on new and upcoming regulations
• Create whitepapers on new regulations to document internal procedures and provide basis for communications to customers on related topics
• Review and advise on risks documented in Safety Data Sheets
• Create and maintain the Regulatory calendar for submissions
• Audit complaints in order to ensure compliance to internal procedures on Adverse event reporting and timing
• Review and Approve label proofs
• Perform any other Regulatory duties as department workload may demand.

This is an office position (sedentary to light). Physical activity would be limited.

This is an office position (sedentary to light). Physical activity would be limited.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Sufficient visual acuity to allow for work done on a computer, reading documents and forms (normal or corrected).

This is an office position within a factory.

Bachelor’s degree with 2 years of Quality or Regulatory experience or equivalent Quality or Regulatory experience (5 years of Regulatory Compliance experience)

This position requires excellent attention to detail, organizational and communication skills. Experience with FDA representatives regarding filing of OTC drug registrations and OTC establishment registrations for products and manufacturers is preferred. Successful candidates should have experience with customer service related activities, and providing technical assistance in support of Sales.

This position requires proficiency with Microsoft Word and Microsoft Excel. A working knowledge of Microsoft Access is desired. Candidates must also be familiar with the various programs/websites used in completing and submitting OTC drug listings (e.g., FDA XForm or equivalent software for creating structured product labeling files for submission).

N/A

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.