Regulatory Manager

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Title: Regulatory Manager
Reports to: VP New Business Development
 
 
Oversee company’s global compliance with federal and state regulating bodies including EPA, FDA, NASC, and AAFCO … liaison with legal counsel and regulatory consultants.
 

    Key contact for regulating agencies, consultants, and legal advisors for the globe, including federal, state and local agencies.  Conducts regulatory risk assessment and action negotiation.
    Directs regulatory processes including daily review and approval of marketing and sales communications, advertising, internal and external distributed documents including print copy, videos, web site, letters and social media.
    Provides all regulatory direction in the development of domestic and international labeling.
    Establishes and maintains legal documents with export partners, responds to requests from international customers for product specific registration requirements and assists in conformity to respective regulatory bodies.
    Represents company with various trade organizations including CSPA, NASC, and membership on various task forces.
    Handles all product liability, adverse reactions and litigation cases and determine the appropriate course of action to take including but not limited to working directly with attorneys, insurance carriers and appropriate regulating bodies.
    Investigates and searches new trademark availability and initiate trademark infringement action while maintaining existing trademarks for domestic and international markets.

    Manages and/ or prepares all required domestic and global product registrations and licenses.
    Maintains compliance to EAR, Anti-Boycott Laws and Prohibited Parties requirements.

    Monitors ingredient levels for REACH compliance based on EU sales.   Determine action needed to maintain compliance.
    Prepares and submits EU CLP registrations and report EU CLP annual sales volumes.
    Develops SPL submissions as required by the Food and Drug Administration.
    Conduct competitive product and ingredient reviews and presents findings.
    Prepares annual budgets for global regulatory, registrations, and legal cost centers.
    Supervision... No direct reports
    Commercialization of Products.
    Will not have Pre-Approval or Post Approval responsibility.
     

    Bachelor’s Degree
    This position requires a minimum of 5 years of experience in a regulatory environment, preferably working with the EPA.
    Proficiency using Microsoft Office; including Outlook, Word, PowerPoint and Excel.

Location: East Long Meadow, Mass (Approximately 30 miles from Hartford, CT.