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Regulatory Affairs Associate - Pharmaceuticals

  • Lancaster, SC
  • Direct Hire
  • Job ID: NC107-2690806

Summary of the Position: The Regulatory Affairs Supervisor reports to the Director Regulatory Affairs. The Regulatory Affairs Supervisor supervises the work of the Jr. Regulatory Affairs Administrative Assistant and is responsible for the day to day activities associated with regulatory affairs.

Roles and Responsibilities:

  • Providing input on policies and objectives involving matters of federal and state government regulations that affect Company Products
  • Assisting with establishing company positions on applicable federal and state regulations and helping to communicate agreed upon positions internally and externally
  • Working with the Business Unit/Marketing Manager to develop procedures to ensure regulatory compliance including assisting in streamlining the routing process for packaging and promotional items
  • Interfacing with government regulatory agencies and officials on behalf of the Company and fostering communication and relationships with such agencies/officials
  • Maintaining current understanding of the regulatory environment for Company products and communicating any key issues or changes internally
  • Maintain current and develop future listing in the Canadian Low Risk Veterinary Health Products Program
  • Ensuring timely payment and filing of registration, license, reports and fees necessary for Company Products
  • Assisting in providing regulatory subject matter expertise and training to the Company
  • Providing representation to and participation in industry trade groups as requested
  • Working with Production, Quality, Marketing, Legal, New Product Development and other necessary departments as a representative for regulatory affairs matters for Company Products
  • Updating and informing Director of any issues and progress issues of regulatory projects
  • Must be able to effectively communicate with other departments and function within a team environment
  • International Regulatory Activities
  • Maintains all (electronic/hard) files current and organized to minimize staff time to identify, locate, and obtain relevant information in the regulatory document databases
  • Processes requests for export certificates with the USDA
  • Sets-up, organizes and maintains regulatory and government affairs filing system and compliance documents
  • Coordinates and maintains licenses, registrations, applications, renewals for products with International regulatory officials
  • Assists with updating all applicable department/corporate policies
  • Performs research by Internet and/or reviewing files for ingredient acceptance in new markets
  • International label guidance and dossier document development
  • Updates job knowledge by participating in educational opportunities
  • Facilitate translation of International Labels
  • Consumer product regulatory review
  • Perform other assigned duties as may be required in meeting company objectives

 

Minimum Requirements:

3 to 5 years regulatory affairs with a veterinary manufacturer/animal health industry experience. Experience in feeds, nutritional supplements and a pharmaceutical regulation required. Must possess strong organizational and leadership skills with the ability to multitask in a fast-paced environment. Maintain registrations, renewals, and regulatory compliance with minimal supervision. Strong written and verbal communication skills required. Must be computer literate. Prior experience with industry trade associations (AAFCO, NASC, AFIA, PFI) is a must.

 

Education and Experience

  • Bachelor's degree as a minimum
  • Formal training in regulatory compliance, AAFCO, NASC
  • Advance degree such as MBA is a plus
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