The Director of Regulatory Affiars will be responsible for being the regulatory expert in keeping the company compliant with regulatory requirements pertaining to OTC, Dietary Supplement, Homeopathic, and Cosmetic product categories.
Client Details
My client has been in the the health and wellness industry for over 100 years, they focus on a variety of products that cater to everyday health.
Description
- Ensure all product packaging are in compliance with applicable labeling regulations/guidelines.
- Compile and maintain ingredient documentation (ex: Natural, GMO, BSE, TSE, Organic, Sources, ingredient functionalities, etc.) to ensure compliance supporting product claims and registrations.
- Partner with Marketing on claims and claim substantiation.
- Collaborate with marketing to ensure promotional material content is supported by the Product Information, literature, and in accordance with the regulatory guidance.
- Monitor the regulatory environment and keep the company informed of regulatory changes (e.g., registration requirements, Prop 65, organic, clean, natural guidelines).
- Manage and maintain company registrations, licenses, and permits.
- Ensure compliance with local, state, and federal regulatory agencies.
- Complete and maintain product toxicity assessments.
- Complete product registrations (drug listing) and manage annual product re-certifications (OTC).
- Complete and file Structure/Function Claims Notifications (Dietary Supplements).
- Partner with Sales to ensure retailers and distributors obtain required product documentation (WRECS, ReposiTrak, ILs, SDS, COA etc.)
- Manager and complete Annual Product Reviews for OTC products.
- Manage complaint handling program and investigate product quality complaints within specified timelines.
- Assess Adverse Events and ensure Serious Adverse Events are reported to FDA/health authorities on time.
- Support product registrations in international markets.
Profile
- Bachelor’s or advanced degree in scientific field.
- 15+ years of experience in regulated industry (Pharmaceutical, OTC, Dietary Supplement, Cosmetic, Medical Device or Food).
- 10+ years of progressive regulatory compliance experience
- Solid operating skills including timely decisions, managing, and measuring work along with good overall time and project management.
- An effective leader who brings optimism and excitement to others, with an ability to present himself/herself professionally and confidently in large public forums, including representation in the cosmetic community and at the senior levels of the government and public community.
- Proficient in Word, Excel, and PowerPoint with the ability to promptly learn and master regulatory/compliance software.
- In-depth knowledge of FDA regulations (pertaining to OTC, Dietary Supplements, Food, Cosmetics) and ICH guidance documents and other state and federal regulatory developments.
- Strong knowledge of OTC drug, Dietary Supplement, and Cosmetic regulations and labeling requirements.
- Experience in electronic enterprise quality management and documentation systems.
- Demonstrate strong technical ability and skills in assigned work area to include product, process and/or testing knowl
Job Offer
- Hybrid Schedule
- Compensation up to $180k
- Room for growth!
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