May lead or support coordinating activities for clinical trial registration, including redactions ... Experience in Regulatory Labeling (e.g., developing core and local labeling, label negotiations ...
May lead or support coordinating activities for clinical trial registration, including redactions ... Experience in Regulatory Labeling (e.g., developing core and local labeling, label negotiations ...
... coordinating with production teams. The technician also provides guidance on maintaining labeling materials, supports the MES system, and identifies process improvements to ensure accuracy and ...
... coordinating with production teams. The technician also provides guidance on maintaining labeling materials, supports the MES system, and identifies process improvements to ensure accuracy and ...
Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions. * Maintain labeling documentation within eDMS and regulatory tracking ...
Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions. * Maintain labeling documentation within eDMS and regulatory tracking ...
QA Data Coordinator
Charles City, IA · On-site
Label coordination/management-design, etc. * Order labels for Production, check in labels, maintenance of label storage according to cGMP regulations. * Issue and track training records for all ...
QA Data Coordinator
Charles City, IA · On-site
Label coordination/management-design, etc. * Order labels for Production, check in labels, maintenance of label storage according to cGMP regulations. * Issue and track training records for all ...
Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions. * Maintain labeling documentation within eDMS and regulatory tracking ...
Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions. * Maintain labeling documentation within eDMS and regulatory tracking ...
Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions. * Maintain labeling documentation within eDMS and regulatory tracking ...
Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions. * Maintain labeling documentation within eDMS and regulatory tracking ...
Engineer II - Labeling (Remote)
$69K - $102K/yr
Plans, schedules, conducts, and coordinates detailed phases of the labeling process in a part of a major project or total project of moderate scope. * Prepares, creates, and controls labels and ...
Engineer II - Labeling (Remote)
$69K - $102K/yr
Plans, schedules, conducts, and coordinates detailed phases of the labeling process in a part of a major project or total project of moderate scope. * Prepares, creates, and controls labels and ...
Engineer II - Labeling (Remote)
$69K - $102K/yr
Plans, schedules, conducts, and coordinates detailed phases of the labeling process in a part of a major project or total project of moderate scope. * Prepares, creates, and controls labels and ...
Engineer II - Labeling (Remote)
$69K - $102K/yr
Plans, schedules, conducts, and coordinates detailed phases of the labeling process in a part of a major project or total project of moderate scope. * Prepares, creates, and controls labels and ...
QA Data Coordinator
Charles City, IA · On-site
Label coordination/management-design, etc. * Order labels for Production, check in labels, maintenance of label storage according to cGMP regulations. * Issue and track training records for all ...
QA Data Coordinator
Charles City, IA · On-site
Label coordination/management-design, etc. * Order labels for Production, check in labels, maintenance of label storage according to cGMP regulations. * Issue and track training records for all ...
Product and Label Specialist
Irvine, CA · On-site
Bachelor's degree in Business, Marketing, Regulatory Affairs, or related field. * 2-4 years of experience in labeling coordination, regulatory documentation, or product marketing. * Familiarity with ...
Product and Label Specialist
Irvine, CA · On-site
Bachelor's degree in Business, Marketing, Regulatory Affairs, or related field. * 2-4 years of experience in labeling coordination, regulatory documentation, or product marketing. * Familiarity with ...
Bachelor's degree in Business, Marketing, Regulatory Affairs, or related field. * 2-4 years of experience in labeling coordination, regulatory documentation, or product marketing. * Familiarity with ...
Bachelor's degree in Business, Marketing, Regulatory Affairs, or related field. * 2-4 years of experience in labeling coordination, regulatory documentation, or product marketing. * Familiarity with ...
Product and Label Specialist
Brea, CA · On-site
Bachelor's degree in Business, Marketing, Regulatory Affairs, or related field. * 2-4 years of experience in labeling coordination, regulatory documentation, or product marketing. * Familiarity with ...
Product and Label Specialist
Brea, CA · On-site
Bachelor's degree in Business, Marketing, Regulatory Affairs, or related field. * 2-4 years of experience in labeling coordination, regulatory documentation, or product marketing. * Familiarity with ...
Product and Label Specialist
Pomona, CA · On-site
Bachelor's degree in Business, Marketing, Regulatory Affairs, or related field. * 2-4 years of experience in labeling coordination, regulatory documentation, or product marketing. * Familiarity with ...
Product and Label Specialist
Pomona, CA · On-site
Bachelor's degree in Business, Marketing, Regulatory Affairs, or related field. * 2-4 years of experience in labeling coordination, regulatory documentation, or product marketing. * Familiarity with ...
QA Data Coordinator
Charles City, IA · On-site
Label coordination/management-design, etc. * Order labels for Production, check in labels, maintenance of label storage according to cGMP regulations. * Issue and track training records for all ...
QA Data Coordinator
Charles City, IA · On-site
Label coordination/management-design, etc. * Order labels for Production, check in labels, maintenance of label storage according to cGMP regulations. * Issue and track training records for all ...
Our Client is looking for Labeling Analyst The Lifecycle Labeling Analyst is responsible for: 1.1.1. Under very limited to no supervision and at times independently coordinates lifecycle product ...
Our Client is looking for Labeling Analyst The Lifecycle Labeling Analyst is responsible for: 1.1.1. Under very limited to no supervision and at times independently coordinates lifecycle product ...
Coordinator, Label Operations A little bit about our team: The Label Operations team at Atlantic Music Group is dedicated to managing our music efficiently and effectively from A&R handoff to ...
Coordinator, Label Operations A little bit about our team: The Label Operations team at Atlantic Music Group is dedicated to managing our music efficiently and effectively from A&R handoff to ...
Coordinator, Label Operations A little bit about our team: The Label Operations team at Atlantic Music Group is dedicated to managing our music efficiently and effectively from A&R handoff to ...
Coordinator, Label Operations A little bit about our team: The Label Operations team at Atlantic Music Group is dedicated to managing our music efficiently and effectively from A&R handoff to ...
Description We are looking for an experienced Communications Coordinator to manage and streamline Clear Label's internal and external communications. In this role, you will be responsible for ...
Quick apply
Description We are looking for an experienced Communications Coordinator to manage and streamline Clear Label's internal and external communications. In this role, you will be responsible for ...
Responsible for coordinating and developing packaging and labeling artwork for new and existing medical device products related to acquisitions, including supporting review, approval, and ...
Responsible for coordinating and developing packaging and labeling artwork for new and existing medical device products related to acquisitions, including supporting review, approval, and ...
The role requires coordinating with Regulatory, Medical, Safety and Clinical teams to ensure accurate, compliant labelling across products and markets. The candidate will guide development of core ...
The role requires coordinating with Regulatory, Medical, Safety and Clinical teams to ensure accurate, compliant labelling across products and markets. The candidate will guide development of core ...
Labeling Coordinator information
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$16.11 is the 25th percentile. Wages below this are outliers.
$14.18 - $16.11
25% of jobs
$16.11 - $18.03
13% of jobs
$18.03 - $19.95
0% of jobs
$19.95 - $21.88
5% of jobs
The median wage is $22.72 / hr.
$21.88 - $23.80
17% of jobs
$23.80 - $25.72
4% of jobs
$25.72 - $27.64
4% of jobs
$27.64 - $29.57
4% of jobs
$30.53 is the 75th percentile. Wages above this are outliers.
$29.57 - $31.49
6% of jobs
$31.49 - $33.41
11% of jobs
$33.41 - $35.34
10% of jobs
$14
$24
$35
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Associate Director, Regulatory Labeling and Disclosures
Cambridge, MA • On-site
Full-time
Posted 10 days ago
Job description
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
The Associate Director, Regulatory Labeling and Disclosures, will be responsible for leading global labeling activities for development and/or marketed products, and leading disclosure activities for applicable clinical trials. The Associate Director is responsible for the development, maintenance, and harmonization of core labeling (e.g., CCDS) and local labeling, ensuring compliance with applicable regulatory requirements while supporting business and lifecycle objectives. The Associate Director may also oversee the end-to-end operations for clinical trial registration, maintenance and results posting on Health Authority-managed databases worldwide (e.g., Clinicaltrials.gov, EudraCT). The Associate Director is responsible for effectively partnering and engaging with internal (e.g., cross-functional study teams, senior management) and external key stakeholders (e.g., vendors, business partners) to ensure business needs and regulatory requirements are met, prioritized, and communicated.
The Opportunity to Make a Difference
Primary Responsibilities Include:
- Leads cross-functional labeling teams to develop and maintain US Full Prescribing Information and associated local labeling documents, Company Core Data Sheets (CCDS), and Target Product Labeling (TPL) for marketed and development products
- Contributes to the formulation of global labeling strategy and assists international regulatory colleagues in development of local or regional labeling consistent with reference labeling
- Responsive to business goals offering creative and compliant solutions while ensuring company regulatory integrity and consistency in communications and activities
- Ensures alignment between reference labeling and regional adaptations while supporting affiliate needs
- Collaborates with cross-functional leads on package labeling (artwork) development, updates, and maintenance
- Supports Global Regulatory Strategists with HA interaction labeling strategy, including submissions, responses to questions, and negotiations.
- May lead or support coordinating activities for clinical trial registration, including redactions of clinical trial documents, registration maintenance and results posting to clinicaltrials.gov, EU CTIS, and similar databases worldwide in compliance with procedures, and applicable regulations
- Manage process for individual participant data (IPD) report generation at the end of clinical studies and act as point on external IPD requests received through Sarepta's privacy team
- Building and maintaining relationships with the Global Regulatory Affairs team, cross functional contributors, and the external vendors to support effective, efficient communication and maintain clinical trial disclosure and transparency compliance, accuracy, and completeness
- Involved in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect
- Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs
- Maintains knowledge of relevant evolving regulation and guidance
- Key contributor within Global Regulatory Teams to establish and implement regulatory strategy
- Interacts across levels and line functions to lead team through successful engagements with Health Authorities
More about You
- BS in related field with 10+ years of related experience. Strong scientific education preferred.
- Experience in Regulatory Labeling (e.g., developing core and local labeling, label negotiations with Health Authorities) and/or Disclosures (e.g., publishing applicable clinical trial registrations and/or results), preferred
- Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and regulatory systems.
What Now?
We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Onsite
This position requires work on site at one of Sarepta's facilities in the United States.
The targeted salary range for this position is $160,800 - $201,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
About Sarepta Therapeutics
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1,001 - 5,000 Employees
Headquarters location
Cambridge, MA, US
Year founded
1980