Senior Regulatory Affairs Officer

RESPONSIBILITIES:

• Work closely with Nature’s Rule Product Development to review formula proposals to ensure that ingredients meet NFSA Standards of Evidence for Identity, Strength, Purity, Limits on Contaminants and substantiation of nutrient content and absence claims
• Set Standards of Evidence for technical reviews and testing requirements to support certain claims made in labeling (i.e., GMO, Allergens, etc.), and ensure alignment with the corresponding regulatory expectations of NFSA.
• Review proposed raw material supplier change control to ensure there is no impact on labeling and product marketability
• 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 before the release to the printer
• Prepare registration Documents of all new products and Re-registered products.
• Follow up all steps of registration with NFSA.
• Coordinate between Nature’s Rule Teams locally and internationally to get the required documentation.
• Ensure all registration activities are following the company and National laws & regulations.
• Maintains change control system and version control for all labeling
• Interface with the document reviewers and approvers to align wording, requirements, and deliverables as needed to facilitate the approval process

Job Requirements

• Bachelor’s Degree in Science, Chemistry, Biochemistry, Pharmacology, Biology, Food Service, or related field; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job required
• Advanced degree (MBA, Master’s) preferred
• 5+ years 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 Electronic Quality Management System (eQMS) preferred
• High degree of proficiency MS Office Suite, Outlook & Internet applications
• Strong analytical, prioritizing, interpersonal, problem-solving, presentation, budgeting, project management (from conception to completion), & planning skills
• Strong verbal and written communication skills (including analysis, interpretation, & reasoning)
• 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