Regulatory Specialist
Procurement & Supply Chain/Quality Assurance
LHH
$65,000.00 - $70,000.00 per Year
Commack, New YorkPermanent
Quality Assurance
Procurement & Supply Chain
Regulatory Specialist
Position Responsibilities:
Collaborate with international teams and suppliers to maintain and create comprehensive customer survey/questionnaires, product certifications, and provide requested documentation promptly.
Serve as a liaison between suppliers and customers to deliver required regulatory, quality, and technical information accurately and efficiently.
Manage and organize Regulatory department databases, ensuring all records are up-to-date and easily accessible.
Assist in addressing various customer complaints following established in-house SOPs.
Support the filing and maintenance of product and facility registrations with FDA and/or NY State for pharmaceutical and nutritional ingredients.
Review product Certificates of Analyses to ensure compliance with approved specifications.
Work closely with the logistics team to provide necessary product intended use letters and resolve FDA-related import issues.
Foster strong relationships with both suppliers and customers, providing support as needed.
Lead new project initiatives (Quality/Regulatory or otherwise) as directed by senior management.
Undertake additional tasks/projects as assigned by the management team.
Position Qualifications:
Bachelor's degree in a scientific, pharmaceutical, or quality-related field.
Minimum of 3–5 years of experience in the Pharmaceutical and/or Nutritional industries in a Laboratory, Quality Assurance, or Regulatory role.
Experience in pharmaceutical/nutritional manufacturing and laboratory operations is highly desirable.
Direct experience with filing product and facility NDC registrations, DMFs, COSs, and interacting with FDA/EDQM is highly desirable.
Proficiency in English; bilingual in English/Chinese is a plus.
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
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy
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
Regulatory Specialist
Procurement & Supply Chain/Quality Assurance
LHH
$65,000.00 - $70,000.00 per Year
Commack, New YorkPermanent
Quality Assurance
Procurement & Supply Chain
Regulatory Specialist
Position Responsibilities:
Collaborate with international teams and suppliers to maintain and create comprehensive customer survey/questionnaires, product certifications, and provide requested documentation promptly.
Serve as a liaison between suppliers and customers to deliver required regulatory, quality, and technical information accurately and efficiently.
Manage and organize Regulatory department databases, ensuring all records are up-to-date and easily accessible.
Assist in addressing various customer complaints following established in-house SOPs.
Support the filing and maintenance of product and facility registrations with FDA and/or NY State for pharmaceutical and nutritional ingredients.
Review product Certificates of Analyses to ensure compliance with approved specifications.
Work closely with the logistics team to provide necessary product intended use letters and resolve FDA-related import issues.
Foster strong relationships with both suppliers and customers, providing support as needed.
Lead new project initiatives (Quality/Regulatory or otherwise) as directed by senior management.
Undertake additional tasks/projects as assigned by the management team.
Position Qualifications:
Bachelor's degree in a scientific, pharmaceutical, or quality-related field.
Minimum of 3–5 years of experience in the Pharmaceutical and/or Nutritional industries in a Laboratory, Quality Assurance, or Regulatory role.
Experience in pharmaceutical/nutritional manufacturing and laboratory operations is highly desirable.
Direct experience with filing product and facility NDC registrations, DMFs, COSs, and interacting with FDA/EDQM is highly desirable.
Proficiency in English; bilingual in English/Chinese is a plus.
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
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy
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