SUMMARY
The overall purpose of the Regulatory Affairs Specialist position is to provide regulatory and compliance support, answer regulatory inquiries (from both internal and external sources), serve as an expert resource for the generation of compliant Safety Data Sheets (SDSs) and labels, and provide scientific and regulatory analysis for projects as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
· Review Globally Harmonized System (GHS) compliant Safety Data Sheets (SDS) and labels for compliance that are generated by external author. Author SDSs on an as needed basis.
· Respond to regulatory and compliance inquiries (both internal and external)
· Author regulatory position papers, compliance letters, and Restricted Substances List (RSLs)
· Provide regulatory and compliance approval for all new product activations
· Generate, Maintain, and update chemical and biocidal product labels
· Submit routine regulatory forms and documentation to support registrations
· Provide support for regulatory and compliance projects as needed
EDUCATION and/or EXPERIENCE
Bachelor’s degree from four-year college or university and five to seven years related work experience; or equivalent combination of education and experience
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.
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.
OTHER QUALIFICATIONS
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. Travel is seldom, up to 10% of the time.
Job Type: Full-time
Pay: $80,000.00 - $90,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Retirement plan
- Tuition reimbursement
- Vision insurance
Schedule:
Supplemental pay types:
Ability to commute/relocate:
- Huntersville, NC 28078: Reliably commute or planning to relocate before starting work (Required)
Application Question(s):
- Are you located in the Charlotte market?
Experience:
- FDA regulations: 1 year (Preferred)
Work Location: Hybrid remote in Huntersville, NC 28078
