Regulatory Affairs Specialist

iHerb • Irvine, CA

23d • $69,510 - $126,382

About The Position

Job Summary: The Regulatory Affairs Specialist will provide support to the Director of Regulatory Affairs in relation to the Company’s regulatory compliance efforts. Job Expectations: 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 The duties and responsibilities described above may provide only a partial description of this position. This is not an exhaustive list of all aspects of the job. Other duties and responsibilities not outlined in this document may be added as necessary or desirable, with or without notice.

Requirements

• 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
• 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, or a combination of education and equivalent work experience

Nice To Haves

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

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees