Regulatory Affairs Specialist

Job Description

• Work closely with Nature’s Rule Product Development to review formula proposals to ensure that ingredients meet NFSA Standards of Evidence for Identity.
• Review and approve finished scripts and is responsible for the accuracy and content for all Nature’s Rule Branded labeling
• Review and approve critical elements of labeling prior to the release to the printer
• Prepare registration Documents of all new products and Re-registered products.
• Follow up all steps of registration with NFSA.
• Maintains change control system and version control for all labeling
• Interface with the document reviewers and approvers to align wording, requirements and deliverable as needed to facilitate approval process.
• Calculate and review the products’ supplement facts.

Job Requirements

• Bachelor’s Degree in Science, Chemistry, Biochemistry, Pharmacy, Biology, or related field.
• 3+ years of progressive Quality or Product Development experience in a cGMP or regulated manufacturing industry preferred
• Technical writing experience in a compliance environment or a scientific environment such as microbiology, food science, chemistry or biochemistry and Quality Management System (QMS) preferred.
• High degree of proficiency MS Office Suite, Outlook & Internet applications.
• Strong analytical, prioritizing, interpersonal, problem-solving, presentation, & planning skills.
• Solid understanding and application of mathematical concepts
• Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external clients
• Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment.
• Ability to work with and influence peers and senior management
• Self-motivated with critical attention to detail, deadlines, and reporting