SPECIALIST REGULATORY

VIVOS HOLDINGS•Overland, MO

1d•Onsite

About The Position

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.

Requirements

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.
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).
This position requires proficiency with Microsoft Word and Microsoft Excel.

Nice To Haves

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.
A working knowledge of Microsoft Access is desired.

Responsibilities

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.