Regulatory Affairs Specialist

The overall purpose of the Regulatory Affairs Specialist position is to provide regulatory and compliance expertise in targeted regions, specifically the EU, ensuring that Microban’s products are registered properly with the appropriate authorities in targeted regions, answer regulatory inquiries (from both internal and external sources), and provide scientific and regulatory analysis for projects as needed.

The person in this position must be a self-starter, coordinate and work well with teams in support roles and with teams in multiple geographic territories; interface with key company stakeholders globally including sales, R&D, supply chain, innovations, quality, marketing, and customer service; and effectively collaborate and communicate with these departments to meet company expectations and consumer/partner demands. Demonstrated expertise in EU and UK REACH and BPR regulatory frameworks is considered a significant advantage for this role.

This role has potential to support other countries in the future. This is a hybrid position based out of Melton Mowbray.

• Manage registration expansion into a targeted region(s) in addition to maintaining and defending registrations in the targeted region(s)
• Always provide excellent internal and external customer support
• Prepare and submit regulatory product registrations to appropriate authorities in targeted regions
• Strategize in new business areas (e.g., antiviral technologies) to provide compliance guidance in targeted region(s)
• Oversee product Safety Data Sheets (SDS) and labels to ensure that regional standards are met to support product distribution
• Prepare and provide documentation to customers related to industrial chemical compliance, biocide chemical compliance, inventory certifications, food contact approval status, registration status and other global regulation compliance
• Author regulatory position papers, compliance letters, and Restricted Substances List (RSLs)
• Provide regulatory and compliance approval for all new product activations in applicable region(s) according to regulatory expertise
• Submit routine regulatory forms and documentation to support registrations
• Work with and manage regional consultants for regulatory projects as needed
• Provide support for regulatory and compliance projects as needed for targeted regions
• Performs other duties as requested

This job has no supervisory responsibilities.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor’s degree from four-year college or university and two to six years related work experience; or equivalent combination of education and experience.

Candidate must have regulatory experience with BPR-type registrations, broad knowledge of REACH, and chemical management systems. Experience with other registration systems (i.e., Medical Devices, etc.), chemical control regulations, environmental regulations, ISO certifications, and customs is preferred.

Strong command of verbal and written English communication skills and strong presentation skills are a must. Ability to read, interpret and understand global regulations relating to antimicrobial, odor control, chemical control, and environmental control and thereafter provide comprehensive and constructive guidance to the business; ability to respond to inquiries or complaints from customers, regulatory agencies, or members of the business community.

Ability to effectively present information to top management, public groups, and/or boards of directors.

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry; ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Ability to define problems, collect data, establish facts, and draw valid conclusions; ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Must have basic understanding of toxicology and ability to apply to regulatory concepts (EPA-FIFRA, PMRA, BPR, REACH, TSCA); ability to extract key concepts from complicated regulatory documents; strong project management and time management skills; ability to prioritize work based on business needs. Must have excellent interpersonal skills; good verbal and written communication skills, critical thinking skills; and the ability to work independently without supervision.

Ability to interpret regulatory language and guidelines; to coherently, convincingly and…