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Regulatory Affairs Specialist

$63k - $105k

Otsuka Pharmaceutical Co., Ltd

MegaFood, a Certified B Corporation and 1% for the Planet member, leverages 50+ years of scientific experience to thoughtfully craft quality supplements made with real food & nutrients that your body knows how to absorb. Since our founding in 1973, MegaFood has been committed to providing people safe, high quality supplements and takes food safety and quality seriously. MegaFood products are tested for 150+ pesticides are NSF GMP certified and are made without the top 9 food allergens (milk, eggs, peanuts, tree nuts, soy, wheat, fish, shellfish, and sesame.) MegaFood is also Certified Plastic Neutral through its partnership with rePurpose Global and has enabled recovery of over 740,000 pounds of nature-bound plastic since it became certified in 2023. Learn more at megafood.com or follow @megafood on Instagram, @realmegafood on TikTok and @MegaFood on LinkedIn.This role is not available for any form of immigration sponsorship or support, including completion of the Form I-983 training plan required for STEM OPT.This role is open to remote candidates not within a commutable distance to our New Hampshire Location. If within a commutable distance, the flexibility schedule will be hybrid, 2 days a week in the office.POSITION SUMMARYThe Regulatory Affairs Specialist supports MegaFood compliance with U.S. and international regulatory requirements for dietary supplements, ensuring products, labeling, claims, and marketing materials meet applicable laws and industry standards. This role works cross-functionally with Quality, R&D, Marketing, Legal, and Supply Chain to enable compliant innovation while mitigating regulatory risk.KEY RESPONSIBILITIESRegulatory Compliance & StrategyMonitor, interpret, and communicate regulatory requirements related to dietary supplements, including FDA, FTC, cGMP (21 CFR Part 111), DSHEA, and relevant state regulations.Support regulatory strategy for new product development, reformulations, and line extensions.Maintain awareness of evolving regulatory trends, enforcement actions, and industry guidance affecting dietary supplements.Labeling & Claims ReviewReview and approve product labels, packaging, ingredient statements, Supplement Facts panels, and allergen disclosures for regulatory compliance.Evaluate structure/function, health-related, and marketing claims to ensure compliance with FDA and FTC requirements.Support submission and maintenance of FDA structure/function claim notifications.Product & Ingredient SupportAssess regulatory status of raw materials, excipients, and finished products (including GRAS status, dietary ingredient classification, and NDI considerations).Support development and maintenance of regulatory documentation for ingredients and finished goods.Prepare, submit, and maintain documentation for third-party product certifications, serving as the primary regulatory liaison with certifying bodies.Liaise with certifiers, suppliers and co-manufacturers to request, evaluate, and maintain regulatory and quality documentation required for product compliance and certifications.Cross-Functional CollaborationPartner with R&D and Product Development to provide regulatory guidance throughout the product lifecycle.Collaborate with Marketing and Brand teams to enable compliant communications without compromising brand voice.Support Quality and Supply Chain teams during audits, inspections, and supplier qualification activities.Documentation & SystemsMaintain regulatory files, approvals, and records in internal systems.Support responses to regulatory inquiries, customer requests, and internal compliance questions.Assist with SOP development and continuous improvement initiatives related to regulatory processes.QUALIFICATIONSRequiredBachelor’s degree in Regulatory Affairs, Life Sciences, Nutrition, Food Science, Chemistry, or a related field.2–5 years of regulatory affairs experience within the dietary supplement industry.Working knowledge of U.S. dietary supplement regulations (DSHEA, FDA, FTC, 21 CFR).Strong attention to detail with excellent written and verbal communication skills.Ability to manage multiple priorities in a fast-paced, collaborative environment.PreferredExperience with structure/function claim substantiation and FDA notifications.Familiarity with international regulatory frameworks (e.g., Canada, EU) a plus.RAC (Regulatory Affairs Certification) or relevant professional certification, a plus.Experience working cross-functionally within a mission-driven or natural products company.Core CompetenciesRegulatory judgment and risk assessment.Cross-functional communication.Technical writing and documentation.Problem-solving and critical thinking.Alignment with the MegaFood values of transparency, integrity, and sustainability.Compensation and BenefitsWe are committed to meeting the needs of our employees and their families with a Total Rewards package that's as comprehensive as the vitamins and supplements we deliver to consumers. With competitive compensation programs and standout benefits, we provide employees with optimal health and well-being - as well as peace of mind. These rewards - plus our new recognition program - ensure employees feel supported both at work and home.SALARY RANGENational Target Base Pay Range: $63,000.00 - $105,000.00 . The salary range for this position is based on national standards. For candidates in California and New York metro the Target Base Pay Range is $71,000 - $118,000 , to reflect the cost of living and market conditions in those areas.Actual compensation will take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location, education, experience, qualifications and job-related skills. It is not typical for an individual to be hired above the midpoint of the range for their role and compensation decisions depend on the facts and circumstances of each case. This information is provided to applicants in accordance with state and local laws.Base pay is only one component of our total rewards offerings, and we will take the full offering into consideration when presenting an offer of employment. Our total rewards package for this position may also include an annual performance bonus, Medical, dental and vision benefits, 401K match, and other wellness benefits.DISCLOSURE:Any misrepresentations or false statements during the application process, including regarding U.S. work authorization and/or the need for immigration sponsorship or support, may result in the rejection of candidacy or the termination of employment.MegaFood is committed to cultivating and preserving a culture of diversity, inclusion and belonging. The collective sum of our individual differences, knowledge, life experiences, and unique talents, represents a significant part of our culture and is the foundation for our accomplishments and impact.MegaFood is an equal opportunity employer. We prohibit employment discrimination and harassment based on race, color, religion, age, sex, sexual orientation, gender, national origin, and any other basis protected by state and federal law. MegaFood recruits, hires, employs, trains, promotes, and compensates individuals solely based on job-related qualifications and abilities.MegaFood also provides reasonable accommodation to qualified individuals with disabilities or based on a sincerely held religious belief, in accordance with applicable laws. If you need to inquire about an accommodation to complete the application process, please email View email address on click.appcast.io .CALIFORNIA FAIR CHANCE ACT:Qualified Applicants with arrest or conviction records will be considered for Employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.JOB ALERT FRAUD:We have become aware of scams from individuals, organizations, and internet sites claiming to represent MegaFood in recruitment activities in return for disclosing financial information.Our hiring process does not include text-based conversations or interviews and never requires payment or fees from job applicants. All of our career opportunities are regularly published and updated on MegaFood.com’s Careers section.If you have already provided your personal information, please report it to your local authorities. Any fraudulent activity should be reported to: View email address on click.appcast.io .DISCLOSURE:Any misrepresentations or false statements during the application process, including regarding U.S. work authorization and/or the need for immigration sponsorship or support, may result in the rejection of candidacy or the termination of employment. #J-18808-Ljbffr Otsuka Pharmaceutical Co., Ltd

Vacancy posted 1 day ago
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