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location:

Holbrook, New York job type: Contract work hours: 9 to 5 education: Bachelors responsibilities: Manage technical queries and maintain regulatory documentation using RDM (Regulatory Data Management) systems. Coordinate international product registration dossiers through Polaris to ensure timely global market access. Prepare and for Certificates of Free Sale (CFS) with state, federal, and local entities (FDA, NY Chamber of Commerce, NJDHHS). Oversee the notarization, apostille, and legalization process for international regulatory approvals. Liaise regularly with contract manufacturers (Co-Mans) and raw material suppliers to obtain technical datasheets, safety documents, and formula details. Maintain real-time data trackers to ensure full visibility of submission statuses, regulatory updates, and team timelines.

qualifications:

Required:

Bachelor's degree. 2-5 years of experience in Regulatory Affairs, Regulatory Operations, Quality Assurance, or Compliance. Hands-on experience with regulatory management software or databases (Polaris, RDM, or similar PLM systems). Knowledge of FDA compliance, state health department regulations, notarization/legalization procedures, and international registration requirements. Proficiency with MS Office (Excel, Teams, SharePoint).

Preferred:

Direct experience in Cosmetics, Personal Care, Dietary Supplements, or OTC/Pharma industries. #LI-HK1 skills:

Regulatory Affairs Operations, FDA Submissions, Accelerated Approval Pathways Equal Opportunity Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). 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Find & Apply For Regulatory Affairs Specialist Jobs in Holbrook, New York

Regulatory Affairs Specialist - Global Market Access & Registrations