Director, Regulatory Affairs (House Brands)

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
  
  

Required

Knowledge, Skills and Abilities

• 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 11 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
  

The anticipated pay scale for this position can be found below, however the pay range applicable to you may vary by geographic location based on where the job is located or where you work. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc. iHerb, LLC is a multi-state employer and this pay scale may not reflect positions that work in other states or locations.

Employees (and their families) that meet eligibility criteria as outlined in applicable plan documents are eligible to participate in our medical, dental, vision, and basic life insurance programs and may enroll in our company’s 401(k) plan. Employees will also be eligible for Time Off and Paid Sick Leave pursuant to the company’s policies. Employees will enjoy paid holidays throughout the calendar year. Eligibility requirements for these benefits will be controlled by applicable plan documents.

Hired applicant may be awarded Restrict Stock Units and receive annual bonuses pursuant to eligibility and performance criteria defined in the respective plan documents and policies.

For more information on iHerb benefits, visit us at iHerbBenefits.com.

Anticipated Pay Scale

$176,534—$264,801 USD


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 50,000 products, from over 1,800 brands direct to our customers in 180+ 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.