iHerb

The Director of Regulatory Affairs is responsible for both Vitamins, Minerals and Supplements and Beauty, Bath and Personal care categories and is to establish and execute challenging decisions based upon sound regulatory knowledge and is to collaborate with the business to provide solutions to regulatory affairs issues.. Provides leadership and expertise for: regulatory operations, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of EC Declaration of Conformity as applicable.. Collaborate with House Brands VMS & BBPC product development , QC, legal, & compliance teams as appropriate on regulatory issues and provide risk assessments as needed to House Brands. Expertise in technical regulations related to dietary supplements, foods, sports nutrition, nutraceutical, and beauty personal care products. BS degree in Food Science, Regulatory Science, Biology, Chemistry, Engineering, or a related

director regulatory affairs

Job Summary:
The Director Regulatory Affairs is responsible for leading the development and implementation of global regulatory strategies for House Brands products to ensure compliance with applicable domestic and international regulatory requirements. The Director of Regulatory Affairs is responsible for both Vitamins, Minerals and Supplements and Beauty, Bath and Personal care categories and is to establish and execute challenging decisions based upon sound regulatory knowledge and is to collaborate with the business to provide solutions to regulatory affairs issues.


Job Expectations:
Provide regulatory direction, guidance, and strategy to ensure compliance with all appropriate government regulations and industry guidelines both domestically and internationally
Determine regulatory submission requirements (i.e., product registrations, certifications, or notifications) according to domestic and international regulations related to changes/new products/claims
Oversee, prepare, and manage various submissions and responses to regulatory authority questions ensuring adherence to national and international regulations and standards (i.e., FDA, Health Canada, European Union)
Provides leadership and expertise for: regulatory operations, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of EC Declaration of Conformity as applicable.
Is the key regulatory advisor to provide strategy and leadership by partnering with operating units on the implementation and training of regulatory requirements.
Anticipate and advise on future regulatory trends and direction, and frequently recommend preemptive approaches for House Brands regulatory compliance.
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements and protocol, including raw material, dosage, efficacy and documentation & labeling requirements.
Review proposed labeling to ensure that the intended use and claims are supported and domestic and international regulations are met and all claims are substantiated with documentations
Review documents for regulatory submissions with attention to detail for quality, regulatory compliance, technical merit, and strategic alignment
Review promotional material and labeling content to ensure compliance with regulatory requirements, consistency, and accuracy
Compile data and documentation necessary for periodic reports for regulatory filings
Manage regulatory staff and consultants both domestically and in key international markets and House Brands VMS scientific advisor
Participates in and contributes to industry and professional meetings to maintain competency on regulatory policy issues, including seminars and tradeshows where appropriate.
Collaborate with House Brands VMS & BBPC product development , QC, legal, & compliance teams as appropriate on regulatory issues and provide risk assessments as needed to House Brands
Assist with Ad Hoc duties and projects


Knowledge, Skills and Abilities:
Required:
Expertise in technical regulations related to dietary supplements, foods, sports nutrition, nutraceutical, and beauty personal care products
Expertise in communicating, interpreting regulatory challenges and proving solutions
Proven experience in developing regulatory strategies and managing regulatory submission for both VMS & BBPC categories
A solution-oriented mindset, providing strategic regulatory recommendations for advancements with the ability to collaborate with House Brands business team
Strong leadership and management skills with the ability to collaborate and communicate across cultures, influencing stakeholders and departments
Experience leading cross functional teams through risk management scenarios
Experience with new product development, engineering change process and 1:1 technical transfers
A hands-on approach with a focus on problem solving and finding creative solutions
Preferred:
RAPS certification desirable, or experience with food/nutrition laws and/or requirements
Experience with cross-border e-commerce sales: D2C & B2B
Experience in regulatory submissions and regulatory interactions in the US, South Korea, Japan, Saudi Arabia, EU, China


Equipment Knowledge:
Experience with Microsoft Office Suite (Word, Excel, PowerPoint)
Experience with Google Business Suite (Gmail, Drive, Docs, Sheets, Forms) preferred


Experience Requirements:
Generally requires a minimum of ten (10) years of scientific background in Regulatory Affairs, or related regulatory or compliance function, with use of analytical and scientific databases


Education Requirements:
BS degree in Food Science, Regulatory Science, Biology, Chemistry, Engineering, or a related


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Staffing Agency Submission Notice
iHerb does not accept unsolicited 3rd party ("Agency") candidates. If you are an Agency, please send any requests to be considered as a supplier in our Vendor Management System to staffingvendors@iherb.com. Do not contact iHerb employees directly. If requested to work on a role, any Agency candidates would be presented through the internal recruiting organization.
About iHerb
iHerb is on a mission to make health and wellness accessible to all. We offer Earth's best-curated selection of health and wellness products, at the best possible value, delivered with the most convenient experience.

We're the world's largest eCommerce platform dedicated to vitamins, minerals, and supplements, and other health and wellness products. For more than 25 years, we've been making it simple for people all over the world to purchase the highest quality products. From supplements to skincare to grocery items, we ship over 30,000 products, from over 1,200 brands direct to our customers in 185+ countries.

Our vision is to become the #1 destination for health and wellness across the world.

With a passion for wellness and a mind for innovative solutions, iHerb team members share a vision for a healthier world that drives them each day. Our 5 Shared Values unite our global team:
Focus on the Customer · Empower Our People · Be Entrepreneurial & Pivot Quickly ·
Embrace Diversity & Inclusion · Strive for Simplicity


iHerb Benefits
At iHerb, we are dedicated to offering programs designed to help our employees and their families stay healthy, live well, and plan for their financial future. Built on a strong foundation, our programs provide options and upgrades with flexibility, protection, and security in mind. For the comprehensive benefits list, visit www.iHerbBenefits.com. For our international team members, you may be eligible for benefits depending on the country where you are employed. The Talent Acquisition Partner/local HR representative will go over the benefits you are eligible for.
iHerb is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. iHerb provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment.

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