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CHCS  Chemical Hazards Communication Society  Promoting the awareness of chemical hazards & improvements in their identification & communication

Regulatory Affairs Specialist

Microban

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Job Title: Regulatory Affairs Specialist
Department: Regulatory
Reports To: Global Senior Manager, Regulatory Affairs
Location: Hybrid position base out of Melton Mowbray

Summary

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.

Essentials Duties and Responsibilities include the following:

  • Manage registration expansion into a targeted region(s) in addition to maintaining and defending registrations in the targeted region(s)
  • 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.
  • Perform other duties as requested

Other duties may be assigned.

Supervisory Responsibilities

This job has no supervisory responsibilities.

Qualifications

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.

Education and/or Experience

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.

Language Skills

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.

Mathematical Skills

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.

Reasoning Ability

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.

Computer Skills

To perform this job successfully, an individual should be proficient in Microsoft Office Suite, web based SDS authoring systems, EPA CDX, IUCLID and internet browsers. The role is expected to use computer-based video and teleconference tools (i.e., Microsoft Teams) as a means of collaboration with team members and external parties.

Other Skills and Abilities

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 appropriately convey (in written and verbal format) regulatory guidance to an array of audiences; able to multi-task and provide regulatory support to multiple business areas within a service standard; and manage staff, consultants and overall project objectives.

Other Qualifications

Must be adept at interpersonal skills to develop and maintain business relationships and determine customer wants and needs; be a self-starter with a tenacious mindset, creativity, and natural curiosity. Must be able to speak, write, and present fluently in English and have a technical background or experience. Previous regulatory experience in the chemical industry is required, experience with antimicrobials is preferred; experience in product safety, assessing hazards and product classifications is required.

Must be able to understand and interpret test reports, toxicology/physical-chemistry data for regulatory submissions, classifications for hazardous products; have excellent writing skills to help craft well-composed regulatory arguments both advocating for and against certain pathways; excellent verbal communication skills to help present arguments or pathways to an array of audiences including customers and internal senior management.

Must be able to travel up to 10% of the time including potential international travel and speak confidently to a range of audiences.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Primarily sedentary with some walking, standing, & carrying light objects. No special vision requirements. Travel is seldom, up to 10% of the time.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Adequately lighted, ventilated, heated/air-conditioned area where normal precautions must be observed such as a typical office environment. The noise level in the work environment is usually moderate (business office with computers and printers, light traffic).


Right to Work:
Applicants must have the legal right to work in the UK. Sponsorship is not available for this role.

Equal Opportunities:
Microban International is committed to equal employment opportunity and prohibits discrimination in accordance with the Equality Act 2010.

Data Protection:
All applications will be processed in accordance with UK GDPR.

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