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Regulatory Affairs Manager

3 months ago

New Britain, United States MicroCare LLC Full time
Job DescriptionJob Description

Imagine working for a company that knows their employees are the key to its success, a company that provides exceptional results while being environmentally conscious and ahead of the curve in research and development; MicroCare LLC is that company. Since 1983, we have been a trusted global provider of critical cleaning solutions with a best-in-class employee population. Currently we are searching for a Regulatory Affairs Manager.

MicroCare, LLC is a distinguished ISO 9001:2015 registered enterprise renowned for its expertise in producing cleaning, coating, and lubricating fluids essential for the fabrication and installation processes across various sectors, including electronics, medical, fiber optic, and metal fabrication industries. Furthermore, we excel in developing specialized solutions for cleaning, coating, lubrication, and infection prevention, catering specifically to the dental, medical, and veterinary domains.

At MicroCare, we take pride in our pioneering efforts, having introduced numerous environmentally progressive and sustainable products, tailored to meet evolving regulatory requirements and the dynamic needs of our valued customers in the realms of cleaning, coating, and infection prevention.

Voted Best Places to Work two years in a row, we are a company with heart. At all our facilities across the globe, we work in a cheerful, inclusive, and collaborative environment where we respect, encourage, and support our customers, our suppliers and each other. We like to laugh; have fun and we make an important impact.

MicroCare, LLC offers competitive salaries and benefits: Medical, Dental, Disability, 401k plan, Holiday and Paid Time Off. We strive to connect with, engage with and improve the lives of our employees, our customers, and the communities in which we operate. We are headquartered in central Connecticut.

POSITION OVERVIEW:

In this role you will be responsible for implementing and upholding a comprehensive regulatory compliance strategy that spans across diverse jurisdictions (EPA, FDA, REACH, F-Gas, DOT, etc.) incorporating regular audits, robust monitoring systems, and tailored training programs to uphold adherence to regulatory standards.

RESPONSIBILITIES:

  • Monitor and interpret regulations pertaining to chemical manufacturing including EPA, FDA, Reach, F-Gas, DOT, and other relevant standards.
  • Assure product compliance with global chemical control legislation (including CARB, USA EPA SNAP, NA HAZCOM, TSCA, OSHA, EU REACH, WHMIS and ISO-10993 and provides GHS classifications).
  • Develop and maintain a compliance program to ensure adherence to applicable regulations across all company operations.
  • Conduct regulatory assessments and gap analyses to identify areas for improvement and ensure timely implementation of corrective actions.
  • Evaluate the impact of new legislation or rulemakings on chemical regulatory management programs and the company’s diverse product lines and processes. Communicate with the appropriate departments regarding those issues and provide compliance guidance.
  • Manage the registration and approval process for chemical products in accordance with regulatory requirements in the USA, UK, Singapore, China, and other key markets.

  • Prepare and submit regulatory submissions including premarket notifications, registrations, and dossiers, ensuring accuracy and completeness.
  • Maintain comprehensive regulatory documentation including technical files, safety data sheets (SDS), and labeling to support product compliance and market access.
  • Collaborate with cross-functional teams including R&D, manufacturing, quality and legal to ensure regulatory compliance throughout the product lifecycle.
  • Review and advise on compliance during all phases of product development, commercialization, and portfolio maintenance, including formulation guidance, regulatory applicability determination and prioritization, component and product classifications, impact and risk assessment and information management.
  • Identify and assess regulatory risks associated with new products, processes, and business initiatives to advise on risk mitigation strategies.
  • Coordinate and participate in regulatory audits, inspections and inquiries ensuring timely response and resolution of findings.
  • Monitor industry trends, best practices, and regulatory developments to proactively advise Leadership Team on upcoming regulations and standards affecting the industry.
  • Review and advise on marketing claims and intellectual property for MicroCare and competition.
  • Represent the company as needed in industry associations, regulatory forums and working groups.
  • Other duties as assigned.

COMPETENCIES/EXPERIENCE:

  • Comprehensive understanding of domestic and international laws and regulations pertaining to chemical regulatory management – particularly TSCA, Canada DSL/NDSL, EU REACH, Korea REACH, UK REACH, etc.
  • Ability to concurrently lead and/or manage multiple complex projects in a fast paced and complex environment
  • Ability to challenge and influence decision making to diverse groups at all technical levels such as regulatory agencies, other industry representatives, customers, technical consultants, contractors, engineers, attorneys, etc.
  • Self-directed with strong analytical and problem solving skills
  • Ability to effectively navigate and work within in a global and culturally diverse environment
  • Effective leadership capable of managing and developing subject matter experts
  • Detail-oriented mindset with the ability to analyze complex regulatory requirements and translate them into actionable strategies
  • Strong organizational, analytical, and problem-solving skills, with an emphasis on Continuous Improvement / Process Optimization

MINIMUM QUALIFICATIONS:

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

  • Bachelor’s Degree in Science or Engineering, majoring in Chemistry, Chemical Engineering, Regulatory Affairs, Toxicology, Environmental Policy, or Environmental Science
  • Minimum of 7+ years of experience in regulatory affairs within the chemical manufacturing industry, with expertise in EPA, FDA, REACH, F-Gas, DOT, IATA, IMDG, and hazardous materials regulations
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and regions
  • Expert knowledge of SDS authoring, GHS Hazard Classifications, and labeling standards
  • Must be knowledgeable in two or more of the following areas: Hazard Communication, Global Chemical Inventory and Substance Notification, OSHA, REACH, GHS, New Product Assessment, and other related global chemical control regulations
  • Strong computer skills (i.e., Microsoft Office Suite, ERP- Chempax + and SDS software).
  • Proven track record of successfully managing regulatory compliance programs and product registrations in a global environment
  • Travel domestically and internationally as needed, 10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.

PREFERRED QUALIFICATIONS:

  • Master’s degree, PhD in chemistry or related industrial science, or Juris Doctorate in Environmental Law
  • Professional certifications (e.g., CRCM, RAC) and experience with electronic regulatory submission systems
  • 10 or more years’ experience in chemical manufacturing product regulatory discipline.
  • Experience participating with professional associations (e.g., AIHA, SCHC)

PHYSICAL/ENVIRONMENTAL QUALIFICATIONS:

  • Sitting, standing, and typing for extended lengths of time.
  • Continuous keyboard use / repetitive hand motion