Director of Regulatory Affairs
The Director of Regulatory Affairs will manage and execute all regulatory activities for the organization’s biosecurity products on a global basis. The incumbent will provide planning and leadership to the regulatory department, ensuring that appropriate structures, systems, competencies and values are developed and will oversee the preparation and submission of State, Federal and Internal registrations for all biosecurity products. The incumbent will operate as a liaison between regulatory agencies and the corporation and will provide all necessary communication to support this responsibility. The incumbent will provide regulatory support and assistance related to FIFRA registrations to customers, distributors/vendors and the general public and will participate on professional committees and analyze industry correspondence with follow-up and discussion with internal colleagues and other industry participants on relevant issues. The incumbent will manage assigned regulatory compliance personnel and will assist in developing and maintaining systems to comply with regulatory and customer (quality system) requirements. The incumbent will resolve and facilitate resolution of problems including identifying causes to prevent reoccurrence and will ensure that all adverse events are dealt with in accordance to company SOPs. The incumbent will participate in developing short and long term goals that support company objectives and will review and approve all GLP studies and protocols. The incumbent will assist in soliciting outside work and funding to help support rodent research facility and will serve as an active participant on project teams including new product development opportunities, customer solutions opportunities, international registration priorities, due diligence for potential new business or products and will participate in monthly management meetings. The incumbent will participate in EPA audits, will oversee and provide direction to staff for draft labeling of new registrations, will oversee changes to existing labels and will coordinate with product management team to draft and prepare labeling for printing. The incumbent is responsible for approval of printed package labeling. The incumbent will prepare and present regulatory and product related training to sales and support staff, will compose and prepare routine correspondence including letters, faxes and email and will compile and present statistical reports and manage EPA and state reporting requirements. Managing a budget is also required as well as overseeing the maintenance of regulatory files and records.
Qualifications include a science based Bachelor’s degree from a four-year college or university, 5+ years of related experience, ability to effectively present information and respond to questions from clients, managers and the general public and be able to read, analyze and interpret general business periodicals, professional journals, technical procedures and governmental regulations. The successful candidate will have knowledge of Microsoft Office.
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