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The Regulatory Compliance Manager oversees the product-related regulatory compliance activities of client. The role supervises personnel performing regulatory activities as required to ensure compliance with company policies, practices and procedures, as well as applicable domestic and international regulations. Provides strategic regulatory leadership and long-term compliance planning for the client’s global product portfolio.
Essential Duties and Job Responsibilities:
- Serves as a subject matter expert for chemical, disinfectant, and antimicrobial products.
- Develops and implements global regulatory strategies to support product commercialization, lifecycle management, and market expansion.
- Reviews and monitors regulations with respect to global activities.
- Prepares summaries of new and changing regulatory requirements and communicates potential impacts as necessary to senior management.
- Provides regulatory input during product development, formulation changes, and manufacturing changes to assess regulatory impact and approval requirements.
- Coordinates product registration at domestic and international levels.
- Prepares regulatory submissions prior to agency filing.
- Domestic regulatory activities, including EPA and FDA annual volume reporting, as well as product and establishment renewal activities, and US State registrations and renewals.
- Responds to regulatory agency inquiries connected to registrations, notifications and changes.
- Participates in audits and inspections performed by regulatory agencies and prepares supporting and briefing documents as necessary.
- In the area of safety, removes and updates Safety Data Sheets (SDSs) for product portfolio.
- Assists in compliance of product labels and labeling by reviewing label content
- Provides regulatory training and guidance to internal stakeholders to ensure ongoing compliance awareness.
MINIMUM JOB REQUIREMENTS & QUALIFICATIONS
Educational/Training Requirement:
- Bachelor’s degree in scientific discipline such as Chemistry, Biology, Microbiology, Physics, Quality, or Environmental Science.
Experience:
- At least 5-8 years of experience with regulations, SOPs, compliance, and/or quality management in pharmaceutical, biotech, medical, medical product, hygiene, cleanroom engineering/products manufacturing, or other regulated chemical industry.
- Experience with disinfectants, antimicrobials, or biocidal products preferred
Licenses/Certifications:
- N/A
Knowledge, Skills, and Abilities:
- Knowledgeable in domestic and international chemicals.
- Communicates clearly, professionally and concisely, both verbally and in writing.
- Proficiency with Microsoft Word, Excel, and PowerPoint are required.
- Exceptional attention to detail and organizational skills.
- Ability to manage multiple projects and competing priorities.
Safety/Environmental
- Maintains a clean, safe work area in compliance with OSHA standards.
- Maintains awareness and compliance with all current local, state, and federal Environmental regulations, such as all regulations governing the handling and disposal of hazardous waste.
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