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Nutrabolt · 1 week ago

Regulatory Affairs Manager

Austin, Texas Metropolitan Area

Full-time

Onsite

Senior Level

5+ years exp

Nutrabolt is a fast-growing global active health and wellness company known for its innovative performance-oriented brands. The US Regulatory Affairs Manager will lead regulatory strategy for Nutrabolt's brands, ensuring compliance and strategic positioning in the dietary supplement and beverage sectors.

Dietary SupplementsFitnessHealth CareMarketingNutrition

Responsibilities

Develop and implementation of Regulatory strategies for United States dietary supplement, nutrition and beverage products to optimize timing for Regulatory filings and competitive positioning

Review raw material compositions and formulations for technical accuracy and regulatory compliance

Create, maintain files and and develops submissions to FDA

Monitor, analyze and advise the business on existing and emerging trends and requirements

Evaluate new product opportunities for United States brought through Product Development and Innovation teams

Labeling, Advertising and Claims: Review and approve labeling, advertising, and promotional copy, as well as review and approval of label text

Develop regulatory options, associated risk assessments, and recommendations regarding registration pathways, labeling and claims

Develop collaborative partnerships with commercial colleagues to drive business objectives and growth

Interact with Customer Service on product inquiries, FAQs and ingredient list requests

Prepare and update Regulatory procedures and SOP

Qualification

Regulatory strategy developmentFDA complianceLabelingClaims reviewDietary supplement experienceRisk assessmentCommunication skillsAttention to detailCross-functional collaboration

Required

Bachelors degree required, preferably in Nutrition or other life science major

Advanced degrees in a life science preferred, but degrees in other disciplines will be considered with equivalent level of experience in regulatory affairs

5-7+ years of Regulatory experiences in the dietary supplement/nutrition experience preferred

A thorough understanding of FDA and FTC regulatory requirements, in particular DSHEA and advertising standards

Able to handle multiple project and exercise good judgment in prioritizing tasks

Demonstrate the ability to work independently & to interact effectively within various cross-functional groups

Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems

A high level of attention to detail