Director, Regulatory Affairs & Compliance

Bonafide

5d•$143,000 - $265,000•Hybrid

About The Position

The Director, Regulatory Affairs & Compliance provides strategic leadership and oversight of regulatory and compliance activities across the company's product portfolio. This role is responsible for ensuring that existing and new products, ingredients, labeling, claims, and supporting documentation comply with applicable FDA statutes, regulations, and guidance. In partnership with Legal Affairs, the Director also supports compliance with applicable FTC requirements and guidance related to product claims, advertising, and substantiation.

Requirements

Bachelors Degree or equivalent work experience Nutritional, physical, of life sciences
Advanced Degree or equivalent work experience
7-9 years related experience Broad Regulatory management and strategic development
7-9 years related experience Dietary supplements
4-6 years related experience Direct interaction with the FDA
Regulatory Affairs Certifications (RAC)-RAPS Upon Hire
Comprehensive knowledge of laws and regulations in an FDA regulated environment
Knowledge of nutrition and health sciences
Verbal, written, and presentation skills
Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes teamwork, collaboration, influencing, motivating, and team building
Strong strategic thinker with deep business acumen and business analytical skills
Ability to work alone or as part of a team and willingness to “roll up sleeves” and do the work
Demonstrated ability working in a deadline-driven environment and handling multiple concurrent assignments and meeting deadlines
Meticulous attention to detail

Responsibilities

Oversee corporate regulatory requirements for the Women's Health business.
Oversee regulatory compliance across dietary supplements, cosmetics, medical devices, and OTC drug products.
Provide regulatory support and strategic guidance to project teams.
Prepare FDA regulatory submissions, including but not limited to, structure/function claims notifications, GRAS documentation, NDIN submissions, and related technical files.
Provide strategic direction and guidance for dietary supplements, including proactive willingness to engage, learn, and work with outside experts in other categories including medical devices, cosmetics, and OTC drugs.
Apply existing and new FDA regulatory requirements as they relate to company products, procedures, scientific research, and record keeping.
Provide advice regarding potential and existing claims for products (all types), including providing input on possible interpretations and implications of claims, label design and label architecture.
Keep apprised of and assess the impact of new and proposed changes in laws, rulings, regulations and enforcement activities that may affect the use of ingredients, product safety, labeling, advertising, or claims.
Act as a direct liaison with the FDA regarding required submissions to FDA. Respond to FDA requests related to regulatory submissions and other matters, as appropriate.
Actively participate in regulatory committees and other relevant trade association groups and serve as the regulatory voice of the company with respect to ingredients, products, and claims.