Regulatory Specialist I

Job Details

Description

Verdesian Life Sciences is seeking the ideal candidate to fill the role of Regulatory Specialist I in the corporate office in Cary, North Carolina. Candidate should already reside in the Raleigh-Durham, NC area. This role is required to be in the office Mondays through Thursdays and remote working on Fridays. This position is responsible for organizational functions related to domestic product registration and regulatory oversight of assigned Verdesian Life Sciences products, projects, and technologies. The position will be responsible for product registrations throughout USA and Canada for a subset of our products as well as the sole responsibility for tonnage reporting for Verdesian and its legacy companies.

Essential Responsibilities

• Responsible for State Registrations
• Process and pay invoices related to regulatory affairs expenses
• Responsible for pulling Sales Tax by County report to process monthly, quarterly, semi-annual and annual tonnage reporting and mill assessments, including payments and recordkeeping
• Maintain accurate and up-to-date regulatory databases and systems, including tracking of regulatory submissions and approvals
• Prepare and/or review regulatory submissions for assigned domestic or international projects
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
• Review and interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures
• Determine the types of regulatory submissions or internal documentation that are required in situations such as labeling or MSDS/SDS changes, heavy metal analysis documentation, etc.
• Prepare or maintain regulatory files as necessary to obtain and sustain product approval, regulatory compliance and company policies
• Actively participate as directed in the preparation of regulatory documents or submissions
• Prepare additional information or responses as directed or requested by VLS or regulatory agencies
• Coordinate and communicate with internal and external stakeholders regarding regulatory submissions and approvals
• Investigate product stop sales at State level and prepare documentation and submissions to appropriate regulatory agencies as necessary
• Attend and actively participate in relevant State (CDFA) on behalf of and in the best interest of VLS
• Other duties not listed above as assigned by immediate supervisor
  
  

Criteria

• Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense
• Active Learning — Understanding the implications of new information for both current and future problem-solving and decision-making
• Language Skills: This position requires a self-starting, analytical, detailed and organized individual with a considerable degree of good judgment, excellent written and oral communication, self-confidence and the ability to conduct activities without supervision
• Reasoning Ability: The ability to effectively communicate problems and solutions to team members both orally and in writing, and maintain interpersonal relationships is essential. Must possess ability to multi-task several projects with various deadlines, establishing priorities and meeting deadlines while working in a fast-paced environment
• Achieves Results: Self-starter, self-disciplined, detailed and organized. Identifies and resolves problem in a timely manner. Prioritizes and plans work activities and uses time efficiently
• Adaptability & Change Management: Effectively deals with and handles change and uncertainty. Adapts easily and quickly to a changing environment without losing effectiveness
• Personal Development: Listens well and is aware of personal strengths and weaknesses and takes continuous action to improve personal capabilities
  
  

Verdesian Life Sciences is an equal opportunity employer to all, regardless of age, ancestry, color, disability, military or veteran status, national origin, political affiliation, race, religious creed, sex, and sexual orientation.