Regulatory Affairs Associate Analyst
similar job titles: Food Labeling Analyst, Regulatory Affairs Analyst, R&D Regulatory Analyst, R&D Regulatory Coordinator
Location: Frisco, TX; 15~ miles north of Plano, TX
Work Schedule: Hybrid; 3 days on-site, 2-day work from home. No travel required.
Highlights:
This job offers the following:
- Outstanding opportunities with a stable and established organization.
- Opportunity for career advancement
- Relocation assistance is provided as needed.
- Excellent benefits, including:
- Comprehensive healthcare coverage on start date
- Dental
- Vision
- Mental & Financial health services
- 401k + company match
- 5% bonus potential
- Short-term & Long-term Disability Insurance
- Basic Life & AD&D Insurance
- Other quality of life voluntary plans are also offered
Job Summary: Reports to the Senior Manager of Regulatory Affairs. The Regulatory Affairs Associate Analyst is responsible for regulatory compliance in new consumer product launches and maintenance of in-market products. This position will collaborate with other company stakeholders by providing regulatory guidance and label content to their project teams.
Additional responsibilities include monitoring an ever-changing regulatory environment and providing insight into their potential impact to company products. Identifying and proposing ways to improve regulatory processes. A willingness to build positive interpersonal relationships within all parts of the organization.
Desired Work Traits:
- Able to work well with others or independently as needed
- High propensity for learning and applying knowledge
- Detail-oriented in one’s approach to their work.
Minimum Requirements:
- Bachelor of Science or higher in Food Science, Biology, Chemistry, Toxicology, Nutrition or similar is required.
- 1 to 5 years’ experience in an FDA regulated consumer products environment.
- Working experience with FDA Code of Regulations (CFR) 21 Parts 1-199.
- Experience working in claims, processing of substantial claims, ingredient review, graphics review, and label content.
- Previous working experience with a PLM system such as SAP, BSS such as Optiva, and label review software highly preferred.
- Some experience with Continuous Improvement initiatives preferred.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat.
Consider This Before Applying:
- Does this job describe work you would enjoy doing?
- Do you meet most of the minimum requirements?
- Have you considered everything if you would need to relocate?
