Position Description The Associate Labeling Specialist supports regulatory labeling strategy and ... Monitor global labeling regulations, standards, and guidance documents to ensure Applied Medical ...
Position Description The Associate Labeling Specialist supports regulatory labeling strategy and ... Monitor global labeling regulations, standards, and guidance documents to ensure Applied Medical ...
Director, Global Labeling - Regulatory Affairs
Billerica, MA · Hybrid
$159K - $210K/yr
The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company ...
Director, Global Labeling - Regulatory Affairs
Billerica, MA · Hybrid
$159K - $210K/yr
The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company ...
Director, Global Labeling Regulatory
$159K - $210K/yr
Manage the creation and execution of global labeling strategies from early clinical development through commercialization * Manage the day-to-day activities of the team to include the hiring and ...
Director, Global Labeling Regulatory
$159K - $210K/yr
Manage the creation and execution of global labeling strategies from early clinical development through commercialization * Manage the day-to-day activities of the team to include the hiring and ...
Director, Global Labeling - Regulatory Affairs
Billerica, MA · On-site
$159K - $210K/yr
The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company ...
Director, Global Labeling - Regulatory Affairs
Billerica, MA · On-site
$159K - $210K/yr
The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company ...
Position Description The Associate Labeling Specialist supports regulatory labeling strategy and ... Monitor global labeling regulations, standards, and guidance documents to ensure Applied Medical ...
Position Description The Associate Labeling Specialist supports regulatory labeling strategy and ... Monitor global labeling regulations, standards, and guidance documents to ensure Applied Medical ...
Director, Labeling Strategy
Boston, MA · On-site
As Director, Labeling Strategy, you will set the direction for global product information across a leading respiratory and immunology portfolio. You will work across early and late-stage development ...
Director, Labeling Strategy
Boston, MA · On-site
As Director, Labeling Strategy, you will set the direction for global product information across a leading respiratory and immunology portfolio. You will work across early and late-stage development ...
Director, Labeling Strategy
Boston, MA · On-site
As Director, Labeling Strategy, you will set the direction for global product information across a leading respiratory and immunology portfolio. You will work across early and late-stage development ...
Director, Labeling Strategy
Boston, MA · On-site
As Director, Labeling Strategy, you will set the direction for global product information across a leading respiratory and immunology portfolio. You will work across early and late-stage development ...
Director, Labeling Strategy
Boston, MA · On-site
As Director, Labeling Strategy, you will set the direction for global product information across a leading respiratory and immunology portfolio. You will work across early and late-stage development ...
Director, Labeling Strategy
Boston, MA · On-site
As Director, Labeling Strategy, you will set the direction for global product information across a leading respiratory and immunology portfolio. You will work across early and late-stage development ...
Position Description The Associate Labeling Specialist supports regulatory labeling strategy and ... Monitor global labeling regulations, standards, and guidance documents to ensure Applied Medical ...
Position Description The Associate Labeling Specialist supports regulatory labeling strategy and ... Monitor global labeling regulations, standards, and guidance documents to ensure Applied Medical ...
Director, Regulatory Labeling
Hampton, NJ · On-site
$176K - $229K/yr
Define labeling strategies for INDs, BLAs, sBLAs, and post-approval changes * Evaluate clinical, nonclinical, and safety data for labeling impact * Ensure consistency across global labeling documents
Director, Regulatory Labeling
Hampton, NJ · On-site
$176K - $229K/yr
Define labeling strategies for INDs, BLAs, sBLAs, and post-approval changes * Evaluate clinical, nonclinical, and safety data for labeling impact * Ensure consistency across global labeling documents
Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion
New York, NY · On-site
$164K - $216K/yr
Contribute to the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects ...
Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion
New York, NY · On-site
$164K - $216K/yr
Contribute to the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects ...
Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. Our team of ... · Demonstrated global and international experience is required. · Proven project management ...
Quick apply
Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. Our team of ... · Demonstrated global and international experience is required. · Proven project management ...
Director, Regulatory Affairs (Medical Devices)
Denver, CO · On-site
$195K - $245K/yr
Oversee global labeling strategy and ensure alignment with evolving regulatory standards. * Serve as the primary liaison to regulatory authorities worldwide. * Direct major submissions including 510 ...
Director, Regulatory Affairs (Medical Devices)
Denver, CO · On-site
$195K - $245K/yr
Oversee global labeling strategy and ensure alignment with evolving regulatory standards. * Serve as the primary liaison to regulatory authorities worldwide. * Direct major submissions including 510 ...
Position Summary The Global Labeling Systems Lead is responsible for sustaining and advancing all ... support strategic objectives. • Continuous Improvement - Driving continuous improvement means ...
Position Summary The Global Labeling Systems Lead is responsible for sustaining and advancing all ... support strategic objectives. • Continuous Improvement - Driving continuous improvement means ...
Position Summary The Global Labeling Systems Lead is responsible for sustaining and advancing all ... support strategic objectives. Continuous Improvement - Driving continuous improvement means ...
Position Summary The Global Labeling Systems Lead is responsible for sustaining and advancing all ... support strategic objectives. Continuous Improvement - Driving continuous improvement means ...
Supports Lundbeck Product Labeling Committee activities as LPLC reviewer, coordinating and ... strategy and regulatory requirements. * Ensures effective planning and execution of all cross ...
Supports Lundbeck Product Labeling Committee activities as LPLC reviewer, coordinating and ... strategy and regulatory requirements. * Ensures effective planning and execution of all cross ...
Supports Lundbeck Product Labeling Committee activities as LPLC reviewer, coordinating and ... strategy and regulatory requirements. * Ensures effective planning and execution of all cross ...
Supports Lundbeck Product Labeling Committee activities as LPLC reviewer, coordinating and ... strategy and regulatory requirements. * Ensures effective planning and execution of all cross ...
Supports Lundbeck Product Labeling Committee activities as LPLC reviewer, coordinating and ... strategy and regulatory requirements. * Ensures effective planning and execution of all cross ...
Supports Lundbeck Product Labeling Committee activities as LPLC reviewer, coordinating and ... strategy and regulatory requirements. * Ensures effective planning and execution of all cross ...
Labeling Change Manager
San Diego, CA · On-site
San Diego, CA Experienced Project Manager to lead and execute labeling change projects role manages global labeling updates--including IFUs, packaging, artwork, UDI, and e‑labeling--ensuring ...
Labeling Change Manager
San Diego, CA · On-site
San Diego, CA Experienced Project Manager to lead and execute labeling change projects role manages global labeling updates--including IFUs, packaging, artwork, UDI, and e‑labeling--ensuring ...
Establish and maintain global labeling strategy, including oversight of Company Core Data Sheet ... CCDS) development and alignment with regional labeling requirements. Allocate and optimize ...
Establish and maintain global labeling strategy, including oversight of Company Core Data Sheet ... CCDS) development and alignment with regional labeling requirements. Allocate and optimize ...
Global Labeling Strategy information
See salary details
$35.16 is the 25th percentile. Wages below this are outliers.
$28.37 - $35.23
25% of jobs
$35.23 - $42.09
2% of jobs
$42.09 - $48.95
20% of jobs
The median wage is $49.46 / hr.
$48.95 - $55.81
36% of jobs
$55.81 - $62.67
1% of jobs
$62.67 - $69.54
7% of jobs
$69.54 - $76.40
2% of jobs
$76.40 - $83.26
1% of jobs
$83.26 - $90.12
1% of jobs
$90.12 - $96.98
1% of jobs
$96.98 - $103.85
3% of jobs
$28
$53
$103
How much do global labeling strategy jobs pay per hour?
What is Global Labeling Strategy?
What are some common challenges faced by professionals in Global Labeling Strategy roles, and how can they be addressed?
What is the difference between Global Labeling Strategy vs Regulatory Labeling Specialist?
| Aspect | Global Labeling Strategy | Regulatory Labeling Specialist |
|---|---|---|
| Credentials | Typically requires advanced degrees in life sciences or regulatory affairs | Requires similar credentials, often with certifications in regulatory affairs |
| Work Environment | Strategic planning across multiple markets, collaborating with global teams | Focuses on preparing and reviewing labeling documents within regulatory agencies |
| Industry Usage | Used in pharmaceutical and biotech companies for global product compliance | Commonly employed in regulatory affairs departments for labeling submissions |
Global Labeling Strategy involves developing and coordinating worldwide labeling approaches, ensuring consistency and compliance across markets. Regulatory Labeling Specialists focus on preparing and managing labeling documentation for regulatory submissions. While both roles require regulatory knowledge, the strategy role is broader and more global, whereas the specialist role is more technical and document-focused.
What are the key skills and qualifications needed to thrive as a Global Labeling Strategy professional, and why are they important?
Associate Labeling Specialist - Regulatory Affairs
Rancho Santa Margarita, CA • On-site
$71K/yr
Full-time
Medical, Life, Retirement, PTO
Posted 29 days ago
Applied Medical rating
8.0
Based on 23 frontline employees who took The Breakroom Quiz
Job description
Position Description
The Associate Labeling Specialist supports regulatory labeling strategy and quality system compliance within the Regulatory Affairs Labeling team at Applied Medical. This role contributes to the development, review, and maintenance of product labeling across global markets, ensuring alignment with applicable regulations and standards in all regions where Applied Medical products are distributed. The Associate Labeling Specialist works cross-functionally to support labeling projects from design input through final approval, making this an ideal opportunity for professionals with a background in regulatory affairs, quality assurance, or technical writing in the medical device industry. Candidates with experience in labeling compliance, Quality System Regulations (QSRs), or regulatory documentation will find this role a strong fit.
Key Responsibilities
- Lead the planning, coordination, and tracking of labeling projects across multiple departments, ensuring timelines and compliance requirements are met.
- Review and approve product labeling to verify accuracy, completeness, and alignment with applicable global regulations and standards.
- Support the upkeep and continuous improvement of the labeling manual, including design inputs, specifications, and final labeling processes.
- Collaborate with cross-functional teams including Engineering, Quality, and Operations to maintain effective technical communication throughout the labeling lifecycle.
- Monitor global labeling regulations, standards, and guidance documents to ensure Applied Medical's Quality System remains current and compliant.
- Support related quality subsystems, including non-conformances and corrective and preventive actions (CAPA), as they relate to labeling activities.
- Apply labeling software and technical tools to manage translation workflows and documentation requirements across international markets.
Success in This Role Looks Like
- Building a strong foundational understanding of Applied Medical's mission, quality systems, and product lines within the first 30 days by engaging with team resources, Applied Learning courses, and cross-functional discussions.
- Taking on projects that require low to moderate guidance within the first 60 days, demonstrating a clear technical understanding of relevant product lines and contributing meaningfully to team meetings and agendas.
- Acting as a liaison to internal and external customers within the first year, coordinating responses to questions and representing the Labeling team in internal and external audits.
- Identifying and proposing process improvements to labeling systems, workflows, and quality practices on an ongoing basis.
- Leading moderate to complex labeling projects with minimal direction, while proactively troubleshooting obstacles that affect project timelines.
- Providing expertise and guidance to team members across the organization, contributing to a broader culture of quality and continuous improvement.
Position Requirements
This position requires the following skills and attributes:
- Bachelor's degree in Engineering, Physical or Biological Sciences, Regulatory Affairs, or an equivalent technical field of study.
- Demonstrated ability to review, interpret, and apply global labeling regulations, standards, and guidance documents in a medical device or regulated industry environment.
- Strong technical writing skills with experience producing or reviewing regulatory documentation.
- Proven ability to manage multiple projects and priorities simultaneously with attention to detail and consistent follow-through.
- Effective oral and written communication skills, including the ability to present complex topics clearly to stakeholders at varying levels.
- Collaborative mindset with the ability to work independently and as part of a cross-functional team.
- Committed to quality, continuous improvement, and exceeding customer expectations.
- Familiarity with Quality Systems Regulations (QSRs), Good Manufacturing Practices (GMPs), and ISO standards for medical devices.
Preferred
The following skills and attributes are preferred:
- At least one year of experience in Regulatory Affairs or Quality Assurance in the medical device industry.
- Experience working with labeling software or regulatory documentation management tools.
- Exposure to labeling translation workflows and international regulatory submissions.
- Training or coursework in regulatory affairs, quality systems, or a related compliance discipline.
Benefits
- Competitive compensation range: $71000 - $80000 / year (California).
- Comprehensive benefits package.
- Training and mentorship opportunities.
- On-campus wellness activities.
- Education reimbursement program.
- 401(k) program with discretionary employer match.
- Generous vacation accrual and paid holiday schedule.
Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.
Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.
All compensation and benefits are subject to plan documents and written agreements.
Equal Opportunity Employer
Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.
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Benefits
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About Applied Medical
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
1,001 - 5,000 Employees
Headquarters location
Rancho Santa Margarita, CA, US
Year founded
1987