Director of Regulatory Affairs

The Director, Regulatory Affairs is a “hands-on” leadership position that defines and implements regulatory strategies and initiatives that support Microban’s global businesses to maximize business opportunities while ensuring compliance with current and future regulations.

This position will manage all regulatory activities globally for the Company to ensure that Microban’s products are registered properly with the appropriate authorities around the world; represent the Company on several regulatory and standards-setting committees, councils, (etc.); and deliver support to external customers as required by the business as well as guidance and training to internal stakeholders on important regulatory topics.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Manage regulatory department for global technology company with multiple antimicrobial and anti-odor technologies.
• Manage registration expansion into new and existing regions in addition to existing global product registrations and notifications.
• Revise (and create) work instructions and standard operating procedures for Regulatory Affairs department.
• Provide strategic regulatory guidance to the business in terms of regulatory risks and opportunities in connection with biocidal and disinfectant products regulated by EPA, PMRA, BPR, etc.
• Prepare and submit regulatory product registrations to appropriate authorities globally (US EPA, Canadian PMRA, EU BPR/ECHA, Asian, Central and South American biocide agencies).
• Prepare and submit applications, dossiers, or other data packages to obtain third party certifications such as Oeko-Tex, BlueSign, or others requested by the businesses.
• Oversee product Safety Data Sheets (SDS) and labels to ensure that international standards are met to support product distribution. Assist in ongoing maintenance of SDS system.
• Prepare and provide documentation to customers related to TSCA, FIFRA, inventory certifications, food contact approval status, registration status and other global regulation compliance.
• Review regulatory compliance issues related to new R&D products.
• Participate in meetings and calls with partners and prospects, directing them to key information resources and industry regulations.
• Interpret advice received from outside specialists and present it to management team in a clear and concise manner.
• Strategize in new business areas (e.g., antiviral technologies) to provide compliance guidance in new and developing areas.
• Participate in global industry groups to help drive regulatory developments globally, as well as raise corporate profile on an international scale.
• Formulate and maintain regulatory department budget annually

QUALIFICATIONS

• Bachelor’s degree in chemistry, environmental science, toxicology, chemical engineering or other related science and more than ten years related experience and/or training; or equivalent combination of education and experience is required. Master’s degree is preferred.
• Global regulatory experience with FIFRA-type registrations and chemical management systems. Preference is for someone knowledgeable with Asian and European registration schemes. Experience with other registration systems (i.e., Medical Devices, etc.), chemical control regulations, environmental regulations, ISO certifications, and customs is preferred.
• Must be able to travel up to 20% of the time including international travel.