Job Description
Job DescriptionRegulatory Specialist
Position Responsibilities:
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Collaborate with international teams and suppliers to maintain and create comprehensive customer survey/questionnaires, product certifications, and provide requested documentation promptly.
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Serve as a liaison between suppliers and customers to deliver required regulatory, quality, and technical information accurately and efficiently.
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Manage and organize Regulatory department databases, ensuring all records are up-to-date and easily accessible.
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Assist in addressing various customer complaints following established in-house SOPs.
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Support the filing and maintenance of product and facility registrations with FDA and/or NY State for pharmaceutical and nutritional ingredients.
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Review product Certificates of Analyses to ensure compliance with approved specifications.
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Work closely with the logistics team to provide necessary product intended use letters and resolve FDA-related import issues.
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Foster strong relationships with both suppliers and customers, providing support as needed.
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Lead new project initiatives (Quality/Regulatory or otherwise) as directed by senior management.
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Undertake additional tasks/projects as assigned by the management team.
Position Qualifications:
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Bachelor's degree in a scientific, pharmaceutical, or quality-related field.
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Minimum of 3–5 years of experience in the Pharmaceutical and/or Nutritional industries in a Laboratory, Quality Assurance, or Regulatory role.
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Experience in pharmaceutical/nutritional manufacturing and laboratory operations is highly desirable.
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Direct experience with filing product and facility NDC registrations, DMFs, COSs, and interacting with FDA/EDQM is highly desirable.
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Proficiency in English; bilingual in English/Chinese is a plus.
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Must be detail-oriented, eager to learn, and possess a continuous improvement mindset.
Job Type: Full-time
Schedule: Monday to Friday
Experience: Relevant: 3–5 years (Required)
Salary: $65-70K; based on experience
Location: Commack, NY
Pay Details: $65,000.00 to $70,000.00 per year
Search managed by: Clare Rant
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
- San Francisco Fair Chance Ordinance
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