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iHerb · 1 day ago

Regulatory Affairs Specialist

Irvine, CA

Full-time

Onsite

Senior Level

$70K/yr - $126K/yr

7+ years exp

iHerb is on a mission to make health and wellness accessible to all. The Regulatory Affairs Specialist will support the Director of Regulatory Affairs in managing regulatory compliance efforts, ensuring that the company's products meet all regulatory requirements and assisting in the preparation and submission of necessary documentation.

BeautyDelivery ServiceE-CommerceFood and BeverageHealth CareRetailSoftwareWellness

Comp. & Benefits

Responsibilities

Assist in managing regulatory affairs matters for the company

Responsible for supporting registration/regulatory needs to maintain and further develop the regulatory capability of the Company

Ensure compliance with regulatory requirements for Company’s products

Responsible for preparing and submitting regulatory documents, reviewing labels and other materials for compliance

Updates internal SOPs / forms / work instructions and assists with internal training of associates regulatory and internal processes

Keeping abreast of evolving regulations to support product development and commercialization

Collaborate with cross functional teams to ensure regulatory compliance

Assist in preparing and submitting regulatory documents (product registration dossiers, technical files, labeling, and packing information, to in accordance with applicable regulations)

Provide administrative support with the compilation and maintenance of product regulatory files, ensuring the accuracy and completeness of all required documentation

Support regulatory assessments of product formulas, claims evidence, packaging, and leveling to ensure compliance with local and international regulations

Assign in evaluating ingredient and formula evaluations

Assist in development regulatory guidance documents for cross functional teams

Perform other related duties as required and assigned

Qualification

Regulatory complianceFDA regulationsFTC regulationsRegulatory documentationMicrosoft Office SuiteGoogle Business SuiteAnalytical skillsCommunication skillsTeam collaborationProject management

Required

Strong understanding of regulatory requirements in relation to product compliance

Great collaborator and team player

Effective research and analytical skills

Strong verbal and written communication skills

Demonstrated ability to work independently on projects, effectively meet aggressive deadlines and able to juggle multiple priorities simultaneously

Experience with Microsoft Office Suite (Word, Excel, PowerPoint)

Generally requires a minimum (7) seven plus years of proven experience in regulatory affairs or related roles within the food/dietary supplement and/or cosmetic industry with in-depth knowledge of FDA and FTC regulations relating to claims, labeling, and ingredient acceptability

Bachelor's Degree in science (Food Science, Biology, Chemistry, Biochemistry, or equivalent.)

Preferred

Experience with Google Business Suite (Gmail, Drive, Docs, Sheets, Forms)

Benefits

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.

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.