Regulatory Specialist

About Us:

We are a family of scientists, farmers, and pioneers working toward the development of a modern, global industry. Our core value of Innovative Creativity is why Abstrax Tech, Inc. is a leading innovator of the sensorial experiences that shape the cannabis industry. We specialize in ingredient, processing, and formulation science, focusing on terpene research and its applications in flavor profiles, fragrance, and the discovery of new valuable molecules. Abstrax collaborates with established manufacturers to help advance the industry, working closely with some of the largest and fastest-growing brands to develop custom formulations for products like vape pens, concentrates, topicals, tinctures, alcohol, and more.

Position Summary:

The Regulatory Specialist will play a vital role in ensuring compliance with regulatory standards and guidelines. Your responsibilities will include conducting research and analysis on regulatory requirements, assisting in the preparation and maintenance of regulatory documentation, monitoring compliance, assisting with product registrations, communicating with regulatory agencies and stakeholders, collaborating with cross-functional teams, and staying updated with regulatory changes and industry trends. This is a non-supervisory role that requires strong collaboration with multiple departments.

What You Will Do: (Duties may include, but are not limited to)

• Maintain a safe work environment.
• Demonstrate Good Manufacturing Practices (GMP) and provide support for internal audits and customer visits.
• Strictly follow all SOPs and Procedures.
• Help the department to maintain a document management system compliant with GFSI-SQF.
• Maintain records/logs/matrix to comply with business and regulatory requirements.
• Assist Document Control Specialist to accurately maintain raw material and finished product information databases.
• Utilize information databases to generate finished product documentation and store in highly organized, easily accessible, central location.
• Provide appropriate responses to Customer Questionnaires.
• Manage Case system to support Customer Service, Sales, R&D, QA, QC and Regulatory departments with appropriate raw material and/or finished product documentation.
• Conduct research on regulatory requirements and impact assessment on how they apply to the company's products. This includes staying updated with changes in regulations and industry standards.
• Keep abreast of changes in regulatory requirements, industry trends, and best practices. This knowledge helps in proactively addressing compliance challenges and maintaining a competitive advantage. Identify emerging regulatory and quality related topics of customer interest to VP of Regulatory and Quality.
• Assist in the process of registering new products or making changes to existing products with regulatory agencies. This includes preparing and submitting TTB Formulas Online registration applications and supporting documentation.
• Provide training and education to employees on regulatory requirements, best practices, and compliance procedures. This helps ensure that everyone understands their roles and responsibilities in maintaining regulatory compliance.
• Complete non-routine jobs as assigned by VP of Regulatory & Quality or other management.
• Work cooperatively with co-workers.
• Maintain regular and punctual attendance at work.

Qualities and Skills You Will Need:

• Familiar with the regulation of foods, beverages, and cosmetics under the US FDA, USDA NOP, DEA Drug Precursors, and TTB.
• International food, beverage and cosmetic regulatory experience desirable.
• Extreme attention to detail.
• Excellent oral, written and presentation communication skills.
• Proficiency using Microsoft Office Programs and information databases.
• Ability to define problems, collect data, establish facts, and draw valid conclu-sions.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to read, analyze and interpret common scientific and technical journals.
• Industry specific knowledge of ingredients, ingredient functionality and product formulas.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to effectively plan, organize and prioritize work.
• Ability to work with minimal supervision.
• Ability to work in a fast-paced environment, and manage multiple, changing priori-ties simultaneously.
• Collaborative.
• Ability to sit for long periods of time.
• Visual acuity to perform an activity such as: preparing and analyzing data and fig-ures; transcribing; viewing a computer terminal; extensive reading.
• Can tolerate frequent exposure to fumes or airborne particles.
• Can tolerate a moderate noise level as found in an office environment.
• Available on call as required to support plant operations.
• Can accommodate occasional travel between facilities (as added).
• Self-directed with the ability to work independently.
• High school diploma or GED equivalent.
• Bachelor’s degree in chemistry, biology, or related field of science preferred.
• 2-4 years of related experience and/or training; or equivalent combination of education and experience

Extras:

• Affordable group medical/dental/vision coverages
• Over 3 weeks of paid time off and holidays
• Annual performance reviews
• Abstrax Tech Perks dashboard
• 401K & Match
• Paid Parental Leave

At Abstrax Tech, Inc., we credit our success to the strength and dedication of our teams. We are committed to building a diverse and inclusive workplace where all employees feel valued and empowered to contribute their best work. If you’re passionate about making an impact in a fast-growing industry and want to be part of a team that leads with care and quality, we’d love to hear from you!

Job Type: Full-time

Pay: $73,440.00 - $80,784.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid parental leave
• Paid time off
• Parental leave
• Retirement plan
• Stock options
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Are you willing to undergo a background check?

Ability to Commute:

• Irvine, CA 92606 (Required)

Ability to Relocate:

• Irvine, CA 92606: Relocate before starting work (Required)

Work Location: Hybrid remote in Irvine, CA 92606

Salary : $73,440 - $80,784