Regulatory Affairs Associate Analyst
Regulatory Compliance Analyst
related job titles: Regulatory Compliance Officer, Compliance Analyst, Compliance Coordinator, Regulatory Affairs Compliance Analyst
Job Location: Frisco, TX; situated about 15 miles north of Plano, TX
Work Schedule: Hybrid; 3 days on-site, 2 days remote. No travel required.
This role offers the following:
- Great opportunities with a well-established and secure organization.
- Potential for career growth
- Relocation assistance provided as necessary.
- Excellent benefits package including:
- Comprehensive healthcare coverage from the beginning
- Dental coverage
- Vision care
- Mental & Financial health services
- 401k with company match
- Potential 5% bonus
- Short-term & Long-term Disability Insurance
- Basic Life & AD&D Insurance
- Additional voluntary quality of life plans offered
Job Summary: Reporting to the Senior Manager of Regulatory Affairs, the Regulatory Affairs Associate Analyst is responsible for ensuring compliance with regulations for new consumer product launches and maintaining compliance for existing products. This position requires collaborating with various stakeholders within the company, providing regulatory guidance and label content to project teams.
Additional responsibilities include monitoring changes in regulations and analyzing their potential impact on company products. Identifying and suggesting improvements to regulatory processes. Building positive relationships with all parts of the organization.
Desired Work Traits:
- Ability to work well independently or collaboratively as needed
- Strong aptitude for learning and applying knowledge
- Detail-oriented approach to work
- Bachelor's degree in Food Science, Biology, Chemistry, Toxicology, Nutrition or a related field
- 1 to 5 years of experience in an FDA regulated consumer products environment
- Familiarity with FDA Code of Regulations (CFR) 21 Parts 1-199
- Experience in claims processing, substantial claims, ingredient review, graphics review, and label content
- Previous experience with PLM systems (e.g., SAP, Optiva) and label review software preferred
- Some experience with Continuous Improvement initiatives is desirable
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat
Consider This Before Applying:
- Does this job align with the type of work you enjoy?
- Do you meet most of the minimum requirements?
- Have you considered factors like relocation if necessary?