Regulatory Affairs Manager

Note to applicants: This role is located in Austin, TX. 

Who You Are:

The US Regulatory Affairs Manager will lead regulatory strategy for Nutrabolt brands, Cellucor, C4 Energy, Xtend, Bloom and any future brands in the United States. You will play a critical role in protecting the brands through balanced compliance and strategic positioning.

What You're Good At:

• 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

What You Contribute: 

• 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

In this position, your goals and KPIs will be focused around:

New Product Development

• Ensuring Regulatory review of New Product/Reformulation documents completed within designated launch timelines
• Regulatory submissions completed within designated launch timelines

Ad/Promo

• As part of the review team, ensure all consumer-facing materials receive Regulatory review within agreed upon timelines and are in compliance
• Create & provide metrics of reviewed material

Pharmacovigilance

• Work with Quality and Customer Service to provide metrics around product complaints and adverse events

Why Nutrabolt?

Wellness Benefits

Nutrabolt cares about our teammates’ physical, mental, and financial wellness by providing benefits like: competitive health insurance, life insurance, mental wellness programs, 401K matching, and a Lifestyle Spending Account.

Lifestyle Perks

We offer unlimited vacation paid time off and volunteer time off. You’ll get discounts on C4 Energy, Cellucor, and XTEND products, too!

Family Support 

We want you to reach your full potential at work by taking care of all loved ones at home. We provide paid parental leave, in addition to reimbursement for expenses related to childcare, fertility treatments, legal fees, and more through our Lifestyle Spending Account.

Employment Type: Full-time, Exempt.

Work Environment: Typical office or at-home work environment.