Labeling Specialist
Jersey City, NJ · On-site
Labeling documents include those prepared for FDA submissions, Annual Reports and PSURs in compliance with regulatory requirements and within company timelines. Candidate will be required to work ...
Jersey City, NJ · On-site
Labeling documents include those prepared for FDA submissions, Annual Reports and PSURs in compliance with regulatory requirements and within company timelines. Candidate will be required to work ...
Jersey City, NJ · On-site
Labeling documents include those prepared for FDA submissions, Annual Reports and PSURs in compliance with regulatory requirements and within company timelines. Candidate will be required to work ...
Hampton, NJ · On-site
$176K - $229K/yr
Monitor evolving FDA requirements * Maintain SOPs for labeling and promotional review * Support inspections and audits * Drive continuous improvement within Regulatory Affairs Qualifications
Hampton, NJ · On-site
$176K - $229K/yr
Monitor evolving FDA requirements * Maintain SOPs for labeling and promotional review * Support inspections and audits * Drive continuous improvement within Regulatory Affairs Qualifications
Hampton, NJ · On-site
$176.66 - $229.43/hr
Monitor evolving FDA requirements * Maintain SOPs for labeling and promotional review * Support inspections and audits * Drive continuous improvement within Regulatory Affairs Qualifications
Hampton, NJ · On-site
$176.66 - $229.43/hr
Monitor evolving FDA requirements * Maintain SOPs for labeling and promotional review * Support inspections and audits * Drive continuous improvement within Regulatory Affairs Qualifications
Hampton, NJ · On-site
$176K - $229K/yr
Monitor evolving FDA requirements * Maintain SOPs for labeling and promotional review * Support inspections and audits * Drive continuous improvement within Regulatory Affairs * Bachelor's degree in ...
Hampton, NJ · On-site
$176K - $229K/yr
Monitor evolving FDA requirements * Maintain SOPs for labeling and promotional review * Support inspections and audits * Drive continuous improvement within Regulatory Affairs * Bachelor's degree in ...
Maple Grove, MN · On-site
$40 - $60/hr
Familiarity with FDA labeling regulations, including 21 CFR and Unique Device Identification (UDI) requirements. * Knowledge of EU Medical Device Regulation (EU MDR) labeling requirements.
Quick apply
Maple Grove, MN · On-site
$40 - $60/hr
Familiarity with FDA labeling regulations, including 21 CFR and Unique Device Identification (UDI) requirements. * Knowledge of EU Medical Device Regulation (EU MDR) labeling requirements.
Support compliance with FDA food labeling regulations (21 CFR), federal, state, customer, and certification requirements. * Identify potential regulatory concerns and communicate findings to the ...
Support compliance with FDA food labeling regulations (21 CFR), federal, state, customer, and certification requirements. * Identify potential regulatory concerns and communicate findings to the ...
Swedesboro, NJ · On-site
$80K - $85K/yr
Support compliance with FDA food labeling regulations (21 CFR), federal, state, customer, and certification requirements. * Identify potential regulatory concerns and communicate findings to the ...
Swedesboro, NJ · On-site
$80K - $85K/yr
Support compliance with FDA food labeling regulations (21 CFR), federal, state, customer, and certification requirements. * Identify potential regulatory concerns and communicate findings to the ...
Hicksville, NY · On-site
$70K - $90K/yr
Review and develop product labels to ensure compliance with FDA, USDA, and customer-specific requirements * Create and verify ingredient statements, Nutrition Facts Panels, and allergen declarations ...
Quick apply
Hicksville, NY · On-site
$70K - $90K/yr
Review and develop product labels to ensure compliance with FDA, USDA, and customer-specific requirements * Create and verify ingredient statements, Nutrition Facts Panels, and allergen declarations ...
Rancho Cucamonga, CA · On-site
$50K - $100K/yr
Ensure all packaging complies with FDA labeling rules and any country-specific regulations for export items. * Develop secondary packaging concepts from ideation sketches to digital drafts and color ...
Rancho Cucamonga, CA · On-site
$50K - $100K/yr
Ensure all packaging complies with FDA labeling rules and any country-specific regulations for export items. * Develop secondary packaging concepts from ideation sketches to digital drafts and color ...
Plymouth, WI · On-site
Labeling & Claims Compliance • Reviews and approves product labels to ensure compliance with FDA labeling regulations, including nutrition facts, ingredient statements, allergen declarations, and ...
Plymouth, WI · On-site
Labeling & Claims Compliance • Reviews and approves product labels to ensure compliance with FDA labeling regulations, including nutrition facts, ingredient statements, allergen declarations, and ...
Fresno, CA · On-site
Experience with regulatory compliance (FDA, labeling requirements, etc.). * Proven project management and leadership experience
Fresno, CA · On-site
Experience with regulatory compliance (FDA, labeling requirements, etc.). * Proven project management and leadership experience
Minneapolis, MN · On-site
Interpret and apply FDA and USDA labeling regulations and internal policies * Develop and maintain accurate food labeling data including allergens, nutrition facts, ingredient statements, and claims
Minneapolis, MN · On-site
Interpret and apply FDA and USDA labeling regulations and internal policies * Develop and maintain accurate food labeling data including allergens, nutrition facts, ingredient statements, and claims
Ensure labeling updates comply with FDA, EU MDR, ISO, and other global regulations. Qualifications Bachelor's degree in a relevant field. 4+ years of experience supporting labeling or regulatory ...
Ensure labeling updates comply with FDA, EU MDR, ISO, and other global regulations. Qualifications Bachelor's degree in a relevant field. 4+ years of experience supporting labeling or regulatory ...
Ensure labeling updates comply with FDA, EU MDR, ISO, and other global regulations. Qualifications Bachelor's degree in a relevant field. 4+ years of experience supporting labeling or regulatory ...
Ensure labeling updates comply with FDA, EU MDR, ISO, and other global regulations. Qualifications Bachelor's degree in a relevant field. 4+ years of experience supporting labeling or regulatory ...
Cape Coral, FL · On-site
$140K - $175K/yr
FDA labeling * USDA-APHIS * FDA Prior Notice * HTS Classification * Experience qualifying and auditing domestic and international contract manufacturers. * Experience owning enterprise Quality ...
Cape Coral, FL · On-site
$140K - $175K/yr
FDA labeling * USDA-APHIS * FDA Prior Notice * HTS Classification * Experience qualifying and auditing domestic and international contract manufacturers. * Experience owning enterprise Quality ...
Labeling & Claims Compliance · Reviews and approves product labels to ensure compliance with FDA labeling regulations, including nutrition facts, ingredient statements, allergen declarations, and ...
Labeling & Claims Compliance · Reviews and approves product labels to ensure compliance with FDA labeling regulations, including nutrition facts, ingredient statements, allergen declarations, and ...
... FDA labeling rules (21 CFR 101) preferred · Experience conducting or supporting sensory evaluation preferred Physical Requirements · Ability to sit and stand for extended periods We offer full ...
Quick apply
... FDA labeling rules (21 CFR 101) preferred · Experience conducting or supporting sensory evaluation preferred Physical Requirements · Ability to sit and stand for extended periods We offer full ...
Fresno, CA · On-site
Experience with regulatory compliance (FDA, labeling requirements, etc.). * Proven project management and leadership experience
Fresno, CA · On-site
Experience with regulatory compliance (FDA, labeling requirements, etc.). * Proven project management and leadership experience
The Associate, Regulatory Affairs Labeling and Artwork (remote position): · Supports all aspects ... with FDA, GMP, ISO and other applicable standards and regulations. · Coordinates and prepares ...
The Associate, Regulatory Affairs Labeling and Artwork (remote position): · Supports all aspects ... with FDA, GMP, ISO and other applicable standards and regulations. · Coordinates and prepares ...
Fairfax, VA · Remote
$170K - $200K/yr
Evaluate and apply evidence-based pharmacogenomic guidelines and resources, including CPIC, PharmGKB, DPWG, and FDA labeling. * Engage internal and external stakeholders to support project goals ...
Quick apply
Fairfax, VA · Remote
$170K - $200K/yr
Evaluate and apply evidence-based pharmacogenomic guidelines and resources, including CPIC, PharmGKB, DPWG, and FDA labeling. * Engage internal and external stakeholders to support project goals ...
$10.34 - $10.95
3% of jobs
$10.95 - $11.56
3% of jobs
$11.56 - $12.17
11% of jobs
$12.40 is the 25th percentile. Wages below this are outliers.
$12.17 - $12.78
21% of jobs
The median wage is $13.34 / hr.
$12.78 - $13.40
13% of jobs
$13.40 - $14.01
11% of jobs
$14.01 - $14.62
4% of jobs
$15.05 is the 75th percentile. Wages above this are outliers.
$14.62 - $15.23
13% of jobs
$15.23 - $15.84
14% of jobs
$15.84 - $16.46
3% of jobs
$16.46 - $17.07
4% of jobs
$10
$13
$17

Description:
Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA). Labeling documents include those prepared for FDA submissions, Annual Reports and PSURs in compliance with regulatory requirements and within company timelines.
Candidate will be required to work with limited oversight and have a basic understanding of FDA labeling regulations and FDA guidance to the level of applying them effectively to all work output.
Specific responsibilities include:
Assisting labeling managers with overall labeling process of brand prescription products
Proofreading of package insert as well as packaging components.
Preparing red-line documents and comparison charts
Understanding of working in a digital workflow system and using online proofreading tools
NDC number assignment
Completion of electronic drug listing and conversion of label to structured product labeling (SPL)
Maintenance and posting of correct labels to company websites and Dailymed
Maintain, catalog, and retain all labeling materials in accordance with company policies, procedures, and technologies
Additional labeling / organizational responsibilities as needed
Job-specific Competencies:
Excellent written communication and organizational skills
Works cooperatively with others; can also manage tasks and priorities independently as needed.
Takes responsibility for his/her own performance; promptly notifies his/her manager about any problems that affect his/her ability to accomplish planned goals
Demonstrates flexibility in managing changing priorities and demands
Knowledge of:
Food and Drug Administration (FDA) regulations and guidelines.
Current FDA/Regulatory Affairs submission requirements.
Logistics and work of the pharmaceutical industry.
Current Company policies, practices and procedures, including safety rules and regulations.
Education Required: BA/BS
Education Preferred: BA/BS with a Scientific or Regulatory background
Experience Preferred: 2+ years of pharmaceutical labeling experience; scientific background or familiarity with medical terminology.
Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, and SharePoint
All your information will be kept confidential according to EEO guidelines.
Sourced by ZipRecruiter
Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization. Lancesoft Inc. is one of the highest rated companies in the industry. We have been recognized as one of the Largest Staffing firms and ranked in the top 50 fastest Growing Healthcare Staffing firms in 2022. Lancesoft offers short- and long-term contracts, permanent placements, and travel opportunities to credentialed and experienced professionals throughout the United States. We pride ourselves on having industry leading benefits. We understand the importance of partnering with an expert who values your needs, which is why we're 100% committed to finding you an assignment that best matches your career and lifestyle goals. Our team of experienced career specialists takes the time to understand your needs and match you with the right job Lancesoft has been chosen by Staffing Industry Analysts as one of the Best Staffing Firms to Work for.LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.
Recruiting and staffing services
1,001 - 5,000 Employees
Herndon, VA, US
2000