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• To serve as main point of contact for Industrial Operations for routine regulatory aspects of the defined portfolio.
•In a team environment, to provide logistical and tactical expertise to Regulatory Affairs avian and mammalian teams.
•To determine appropriate regulatory requirements, commitments and actions required to support maintenance and defense of existing licenses.
•To actively participate with non-regulatory team members in integrating the regulatory perspective in project teams related to new product
development or lifecycle management.
•To remain current with regard to USDA laws, regulations, guidelines and/or policy that may impact
Merial and recommend appropriate action to protect the Company's interests.
•In accordance with applicable regulatory requirements and the registration plans as defined by Business Operations,
he/she creates and maintains abbreviated files for international regulatory
submission and provides technical regulatory support to assist timely and efficient registration in all
• Update and maintain abbreviated international dossiers and supporting documentation used to support geographic extensions via new
• Develop work instructions for regulatory processes streamlining where possible
• Review promotional pieces for compliance with regulatory requirements
• Manage the consultation for, assembly, review, and submission of biological product labels and Outlines of Production to the
Center for Veterinary Biologics (CVB) to support compliance and variations
• Secure needed documentation for variations and renewals for licensed product portfolio in International markets
• Provide Quality Assurance (QA) oversight for assembly, review, formatting, circulation, approval, and submission of Outlines of Production,
Special Outlines, and facility documents
• Support organization, archiving, and retrieval of regulatory documents and correspondence
• Help to assemble and provide final QA review for electronic submissions to government agencies including updating documents to
• Maintain regulatory databases, activities charting, and government submission and response tracking
• Help manage the company circulation of all regulatory documents
• Support maintaining the official regulatory archives in Athens, Gainesville, and Duluth as needed
• Help circulate, compile comments, and provide quality review of internal Policy, Procedures, and Guidelines (PPG)
• Provide support for miscellaneous project assignments as needed
• Secure needed import and transport permits or authorizations as needed from local, State, Federal, or international regulatory authorities
• Manage correspondence with State regulatory authorities
• Coordinate with international regulatory colleagues on global initiatives for which US input is required
• 2 or more years of experience in the pharmaceutical, biologics and/or related industries or disciplines dealing with US local, state,
and federal regulatory issues related to in particular those associated with product development, licensure, and maintenance,
licensed manufacturing facilities and related industry matters. Experience interacting with USDA or other government agencies preferred.
• Excellent communication (verbal and written), negotiation, organizational, and teamwork skills
• Committed to performance with attention to details
• Innovative problem solving skills
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