VP of Regulatory Affairs & Compliance

Richardson, TX, United States

Job Description

Job Description

Job Summary:

Will be responsible for leading the company’s regulatory and compliance efforts within the scope of Food and Drug Administration (FDA) laws for dietary supplements and Federal Trade Commission (FTC) claims guidelines. Responsible for overseeing and proactively monitoring the regulatory environment, labeling guidance, and regulatory and legal risk analyses for domestic and potential future international projects.

Areas of responsibility:

Own the strategy for Product Recall

Plan and execute all internal audits and inspections, including GMP audits on production facilities

Create policies and regulations for Brick-and-Mortar scenarios

Manage a compliance team to oversee Vendor & Supplier compliance

Develop & Implement Compliance Policies

Develop & Implement Crisis Management Policies

Oversee all compliance reporting & documentation

Proactively monitor regulations and policies to ensure compliance of all AdvoCare products

Communicate external developments and assess their impact on the Company’s ability to sell products and their ingredients

Develop robust regulatory strategies and proactive solutions

for new product development products and projects

Create and update procedures as agreed upon with management

Provide gap analysis for business model related to current SOP’s

Train employees on current and new procedures

Mentor and direct others on their team and throughout the company in their understanding and application of regulations and guidance

Work with legal department on product labeling and marketing materials to ensure they meet current FDA and FTC standards

Work with the FDA on an as-needed basis

Review and approval of deviations, customer complaints, change controls, qualification and validation oof products, and quality system protocols

Handle customer quality and product safety complaints

Point of contact for FDA inspections (answering requests, defending decisions, etc.)

Provide regulatory advice as requested on product advertising, labeling and promotional materials

Research and remain current on labeling, claims and other regulations in the US and international markets

Work with quality, R&D, supply chain and marketing groups to ensure adherence to regulatory requirements

Set clear priorities, review project progress with the ability to provide gap analysis and resolutions to lead the regulatory team to achieve targets, balance resources, while maintaining quality and speed of products to market

Work with quality group to review product testing results from a regulatory compliance perspective

In conjunction with Product Management, Marketing, and Research and Development, conducts and oversees thorough risk analyses that regulations may have on specific product renovations, new launches, and non-product related situations

Deeply understands supplement and food regulations while demonstrating solid interpretation of those regulations to specific business cases and product launches

Oversee the review of Supplement Facts and Nutrition Facts panels for existing products and new product development projects to support artwork development

Work with customer service, returns, and other applicable groups in cases where a product recall is required

Attributes and Skills

Strong leadership skills

Professional attitude and demeanor

Organized and able to manage multiple tasks

Strong project management skills (for more junior level, project management proficiency)

Detail-oriented

Strong analytical and problem-solving skills, particularly with regards to regulatory issues

Strong communication skills, including, speaking and writing to various levels within and outside of the company

Strong knowledge of cGMP’s

Competency in US and foreign government regulations related to the manufacture, warehousing, and distribution of foods and dietary supplements

Ability to meet deadlines

Ability to manage a team and work in a team environment

Master’s degree in science related field, PhD is a plus

10+ years working in a regulatory affairs position in a federally regulated industry (i.e., foods, dietary supplements, or pharma)

8+ years of personnel management experience

Comprehensive understanding of the Dietary Supplement Health and Education Act (DSHEA) of 1994 and how to apply this knowledge in the review of dietary supplement claims, labeling and advertising

Deep understanding of 21 CFR 101 Food Labeling and 21 CFR101.36 Nutrition Labeling of Dietary Supplements

Understand Section 403 (r) (6) of the Federal Food, Drug, and Cosmetic Act (21 USC 343(r)(5)) substantiation for dietary supplement claims

Ability to influence cross functionally to deliver against business goals and objectives

Leads and directs strategic programs focused on meeting regulatory and compliance requirements

High-level math skills for ingredient and label calculations

Solid understanding of the interrelationship between labeling, artwork, and product regulations

Proficiency in Microsoft Office applications

Experience with internal audit function

Experience working with government regulators

Experience with CPG, specifically powders and ready to drink products

Manufacturing experience a plus

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