Regulatory Specialist

Who we are :

We’re Prime Matter Labs, a personal care product manufacturer with over 40 years of experience formulating, compounding, and filling products for some of the most successful and respected brands in the world.

We exist to bring better products to the world by empowering our customers to bring their ideas to life. We strive to be their most valuable partner, delivering a level of efficiency, service, and support unmatched in the industry.

We’ve embarked on a bold new vision to be the leading product development and production partner in the country for emerging and established brands.

To realize that vision, we’re investing at an unprecedented level in new technology, processes, and plans that will completely rethink the way that brands view and interact with their manufacturer.

We’re building the platform that will allow us to serve as the foundation of our customer’s branded products, from their first sample to their million-unit product run, and every step in between.

Come help us build the future of the personal care and beauty landscape, one partnership at a time.

Overview : The Entry-Level Regulatory Specialist supports the Regulatory Affairs team in ensuring compliance with applicable laws, regulations, and standards governing products or processes within the organization’s industry.

This position provides an opportunity for recent graduates or individuals new to the field to gain practical experience in regulatory affairs and contribute to regulatory compliance activities.

Responsibilities :

Conduct research and gather information on regulatory topics as directed.

Documentation Assistance : Assist in the preparation, review, and organization of regulatory documents, such as applications, registrations, notifications, and reports.

Ensure accuracy, completeness, and organization of regulatory documentation.

Data Management : Maintain regulatory databases, document control systems, and filing systems to track regulatory submissions, approvals, and correspondence with regulatory agencies.

Ensure data integrity and confidentiality of regulatory information.

Product Registration Support : Support efforts to obtain and maintain products approvals, licenses, permits, certifications, or registrations from regulatory authorities.

Assist in compiling documents and responding to regulatory inquiries or requests for information.

Quality Assurance Support : Collaborate with Quality Assurance teams to support compliance with regulatory requirements, quality standards, and Good Manufacturing Practice (GMP).

Assist in documentation review and quality system activities as needed.

• Cross Functional Collaboration : Work collaboratively with cross-functional teams, including Research and Development, Manufacturing, Quality, and Sales to support regulatory compliance initiatives and projects.
• Regulatory Training and Education : Participate in training sessions and educational activities to develop knowledge and skills in regulatory affairs, compliance procedures, and industry regulations.

Actively seek opportunities for learning and professional development.

Administrative Support : Provide administrative support to the Regulatory Affairs team, such as scheduling meetings, maintaining calendars, preparing meeting agendas, and organizing regulatory documentation.

Qualifications :

• Bachelor’s degree or equivalent experience in a relevant field such as Regulatory Affairs, Life Sciences, Chemistry, Pharmacy, Engineering, or related discipline.
• Demonstrated interest in regulatory affairs, compliances, or a related field through coursework, internships, or extracurricular activities.
• Strong attention to detail, organizational skills, and ability to manage multiple tasks effectively.
• Excellent communication, interpersonal, and teamwork skills. Ability to collaborate with cross-functional teams and interact professionally with internal and external stakeholders.
• Proficiency in Microsoft Office applications (e.g., Word, Excel, PowerPoint) and willingness to learn regulatory software and document management systems.
• Motivated, proactive, and adaptable individual with a willingness to learn and grow in a dynamic regulatory environment.
• Commitment to upholding ethical standards, confidentiality, and professionalism in all aspects of work.
• Ability to work independently with guidance and direction from senior regulatory professionals.

What we’re offering :

nbsp; Competitive compensation package.

• Health, dental, and vision benefits.
• 401K program.
• The spirit of a startup with the security of an established, profitable industry leader.
• The opportunity to make waves in a $250B industry.

At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company.

We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer.

Last updated : 2024-05-31