What are the responsibilities and job description for the Senior Regulatory Affairs Specialist I position at Imbibe?
Summary of Position
This individual provides support to internal and external customers in order to ensure that all domestic and global regulatory requirements and compliance needs are fulfilled according to legal and corporate guidelines. They are detail-oriented, highly organized, and comfortable working in a fast-paced environment with everchanging priorities.
Essential Job Duties
- Generate, review, and approve labels for finished products and flavors to ensure accuracy and compliance with legal standards.
- Gather and analyze the necessary data to ensure compliance with domestic (FEMA GRAS, FDA) and international (Health Canada, JECFA, GCC, Mercosur) regulatory requirements for flavors and finished goods.
- Review Nutrition Facts Panels, Supplement Facts Panels, Product Data Sheets, production labels and ingredient declaration for flavors and finished goods.
- Conduct risk assessments to evaluate the regulatory implications of proposed product changes or new ingredients.
- Review and analyze data provided by suppliers of new and existing raw materials; ensure that data entered in internal formulation software is accurate.
- Stay up to date on regulatory changes and understand the implications to the business related to these changes.
- Ability to interpret rules set by governments and certifying organizations including, but not limited to GMO, Bioengineering, Kosher, Allergens, Halal, Prop 65, Organic.
- Identify regulatory challenges relevant to commercial opportunities and serve as a subject matter expert by collaborating cross-functionally to solve them.
- Provide regulatory support to the internal R&D team and external customers.
- Assist in the development of marketing claims for new product concepts.
- Assist with regulatory audits.
- Develop and maintain company SOPs.
Minimum Qualifications
- Bachelor’s degree in chemistry, biology, food science, nutrition, or other related fields.
- 5 years of relevant industry experience in product safety and regulatory affairs in the food industry.
- Excellent understanding of 21CFR101 and 7CFR205/206.
- Ability to make educated judgements on authenticity, accuracy, and appropriateness of information. · Must be able to prioritize and provide input on regulatory aspects
- Must continually demonstrate a very strong attention to detail, careful execution of tasks, and regularly check own work before any submission.
- Flexibility, methodical and rigorous spirit. Ability to work in a collaborative environment.
- Demonstrate excellent verbal and written communication skills.
- Ability to work collaboratively and thrive in a fast-paced and dynamic environment.
- Ability to remain in a stationary sitting position 75% of the time
- Ability to observe details at close range.
Preferred Qualifications
- Working knowledge of US, Canadian, EU & Mexican flavor regulations
Working Conditions
- Office setting
Pay range: $75,000 - $95,000
The salary range listed represents the expected earnings for this role. The low end of the range reflects the starting salary for candidates with less experience or qualifications that meet the basic requirements for the position. The high end of the range reflects potential earnings for candidates with extensive experience, specialized skills, or qualifications above the standard requirements for the role
Benefits
- 401k company contribution match
- Comprehensive medical, dental, and vision care
- FSA and HSA account
- Generous PTO sick time
- Onsite gym
- Parental leave
- Life and disability insurance
Salary : $75,000 - $95,000
