You will define labeling strategy, lead governance committees, and collaborate cross-functionally to deliver compliant, high-quality documentation throughout the product lifecycle. Key ...
You will define labeling strategy, lead governance committees, and collaborate cross-functionally to deliver compliant, high-quality documentation throughout the product lifecycle. Key ...
Labeling & Dispensing Representative
Irvine, CA · On-site
$22 - $28/hr
Follows SOP for dispensing and labeling in an efficient and safe manner with minimum supervision ... Develop and/or take part in key strategies for the ultimate success of SDC's Vision, Mission, and ...
Labeling & Dispensing Representative
Irvine, CA · On-site
$22 - $28/hr
Follows SOP for dispensing and labeling in an efficient and safe manner with minimum supervision ... Develop and/or take part in key strategies for the ultimate success of SDC's Vision, Mission, and ...
Labeling Work Stream Lead
Covington, GA · On-site
The Labeling Work Stream Lead (WSL) willbe responsible forworking with a cross-functional team to develop the labeling content,completethe labeling layout, and working with the manufacturing site as ...
Labeling Work Stream Lead
Covington, GA · On-site
The Labeling Work Stream Lead (WSL) willbe responsible forworking with a cross-functional team to develop the labeling content,completethe labeling layout, and working with the manufacturing site as ...
National Security Strategist This role has been designed as 'Hybrid' with an expectation that you will work on average 2 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise is ...
National Security Strategist This role has been designed as 'Hybrid' with an expectation that you will work on average 2 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise is ...
Enterprise IT Strategist
Baltimore, MD · On-site
We are seeking an IT Strategist / Product Strategist to help shape and advance enterprise technology strategy in a complex, mission-driven environment. This role supports large-scale planning and ...
Enterprise IT Strategist
Baltimore, MD · On-site
We are seeking an IT Strategist / Product Strategist to help shape and advance enterprise technology strategy in a complex, mission-driven environment. This role supports large-scale planning and ...
National Security Strategist This role has been designed as 'Hybrid' with an expectation that you will work on average 2 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise is ...
National Security Strategist This role has been designed as 'Hybrid' with an expectation that you will work on average 2 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise is ...
Granicus is seeking a senior consulting leader to drive strategic engagements with federal enterprise customers, managing multi‑million recurring revenue accounts and cross‑functional teams ...
New
Granicus is seeking a senior consulting leader to drive strategic engagements with federal enterprise customers, managing multi‑million recurring revenue accounts and cross‑functional teams ...
New
Public Affairs Strategist
Washington, DC · On-site
As a Public Affairs Strategist, you'll lead Evolv's work to advance state-level policy that establishes advanced weapons screening as a recognized standard for keeping students and staff safe in K-12 ...
Quick apply
Public Affairs Strategist
Washington, DC · On-site
As a Public Affairs Strategist, you'll lead Evolv's work to advance state-level policy that establishes advanced weapons screening as a recognized standard for keeping students and staff safe in K-12 ...
National Security Strategist This role has been designed as 'Hybrid' with an expectation that you will work on average 2 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise is ...
National Security Strategist This role has been designed as 'Hybrid' with an expectation that you will work on average 2 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise is ...
Public Affairs Strategist
New York, NY · On-site
As a Public Affairs Strategist, you'll lead Evolv's work to advance state-level policy that establishes advanced weapons screening as a recognized standard for keeping students and staff safe in K-12 ...
Quick apply
Public Affairs Strategist
New York, NY · On-site
As a Public Affairs Strategist, you'll lead Evolv's work to advance state-level policy that establishes advanced weapons screening as a recognized standard for keeping students and staff safe in K-12 ...
Public Affairs Strategist
Waltham, MA · On-site
As a Public Affairs Strategist, you'll lead Evolv's work to advance state-level policy that establishes advanced weapons screening as a recognized standard for keeping students and staff safe in K-12 ...
Quick apply
Public Affairs Strategist
Waltham, MA · On-site
As a Public Affairs Strategist, you'll lead Evolv's work to advance state-level policy that establishes advanced weapons screening as a recognized standard for keeping students and staff safe in K-12 ...
Drive enterprise AI strategy, governance, and adoption while empowering teams across the organization to unlock measurable business value through responsible artificial intelligence. This position is ...
Drive enterprise AI strategy, governance, and adoption while empowering teams across the organization to unlock measurable business value through responsible artificial intelligence. This position is ...
Agency MBS Desk Strategist
New York, NY · On-site
$200K - $300K/yr
Responsibilities: • Lead prepayment analytics and strategy for the Agency MBS desk, influencing positioning, risk-taking, and revenue generation. • Work closely with MQA (Market Quantitative ...
Agency MBS Desk Strategist
New York, NY · On-site
$200K - $300K/yr
Responsibilities: • Lead prepayment analytics and strategy for the Agency MBS desk, influencing positioning, risk-taking, and revenue generation. • Work closely with MQA (Market Quantitative ...
Serve as a strategic thought partner to C-suite and senior executives, shaping enterprise AI roadmaps and informing high-stakes transformation initiatives. Lead executive steering forums and decision ...
Serve as a strategic thought partner to C-suite and senior executives, shaping enterprise AI roadmaps and informing high-stakes transformation initiatives. Lead executive steering forums and decision ...
Global Tech Strategist
Wayne, PA · On-site
Act as a trusted strategic thought partner to C-suite business and IT stakeholders, building long-term relationships grounded in deep business, commercial data and technology understanding, proactive ...
Global Tech Strategist
Wayne, PA · On-site
Act as a trusted strategic thought partner to C-suite business and IT stakeholders, building long-term relationships grounded in deep business, commercial data and technology understanding, proactive ...
Public Affairs Strategist
Waltham, MA · On-site
As a Public Affairs Strategist, you'll lead Evolv's work to advance state-level policy that establishes advanced weapons screening as a recognized standard for keeping students and staff safe in K-12 ...
Public Affairs Strategist
Waltham, MA · On-site
As a Public Affairs Strategist, you'll lead Evolv's work to advance state-level policy that establishes advanced weapons screening as a recognized standard for keeping students and staff safe in K-12 ...
As a Public Affairs Strategist, you'll lead Evolv's work to advance state-level policy that establishes advanced weapons screening as a recognized standard for keeping students and staff safe in K-12 ...
As a Public Affairs Strategist, you'll lead Evolv's work to advance state-level policy that establishes advanced weapons screening as a recognized standard for keeping students and staff safe in K-12 ...
AI Enablement Strategist
Dubuque, IA · On-site
Drive enterprise AI strategy, governance, and adoption while empowering teams across the organization to unlock measurable business value through responsible artificial intelligence. This position is ...
AI Enablement Strategist
Dubuque, IA · On-site
Drive enterprise AI strategy, governance, and adoption while empowering teams across the organization to unlock measurable business value through responsible artificial intelligence. This position is ...
Public Affairs Strategist
Waltham, MA · On-site
As a Public Affairs Strategist, you'll lead Evolv's work to advance state-level policy that establishes advanced weapons screening as a recognized standard for keeping students and staff safe in K-12 ...
Public Affairs Strategist
Waltham, MA · On-site
As a Public Affairs Strategist, you'll lead Evolv's work to advance state-level policy that establishes advanced weapons screening as a recognized standard for keeping students and staff safe in K-12 ...
Founding AI Transformation Strategist
New York, NY · On-site
$200K - $260K/yr
They need a strategy, a roadmap, and a clear understanding of where AI can create the greatest impact. This is where Scribe comes in. Scribe Optimize gives enterprises something that hasn't existed ...
Founding AI Transformation Strategist
New York, NY · On-site
$200K - $260K/yr
They need a strategy, a roadmap, and a clear understanding of where AI can create the greatest impact. This is where Scribe comes in. Scribe Optimize gives enterprises something that hasn't existed ...
Labeling Strategist 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 labeling strategist jobs pay per hour?
What is a Labeling Strategist job?
A Labeling Strategist is responsible for developing and managing labeling content for pharmaceutical, biotechnology, or medical device products. They ensure that product labels comply with regulatory requirements, accurately reflect safety and efficacy data, and align with global market expectations. This role involves collaboration with regulatory affairs, medical, legal, and commercial teams to create clear, compliant, and effective labeling strategies. Labeling Strategists also monitor regulatory changes to update labels accordingly and support product approvals. Their work is critical for ensuring patient safety and regulatory compliance.
Which 5 jobs will survive AI?
What are the key skills and qualifications needed to thrive in the Labeling Strategist position, and why are they important?
A Labeling Strategist typically requires deep knowledge of regulatory requirements, product labeling standards, and project management, often supported by a background in life sciences or related fields. Familiarity with labeling management systems, document control software, and regulatory submission platforms such as Veeva Vault or eCTD is common in this role. Exceptional attention to detail, cross-functional communication, and problem-solving skills help individuals excel in navigating complex labeling processes. These capabilities are critical for ensuring accurate, compliant label content and timely global product launches.
What is the highest paying job in pharmaceuticals?
What is a labeling strategist?
How to become a labeling specialist?
What are the most common challenges faced by Labeling Strategists, and how are they typically addressed?
Labeling Strategists often encounter challenges such as managing frequent changes in regulatory requirements, coordinating feedback from multiple stakeholders, and ensuring that all product labels are both compliant and up-to-date across global markets. To address these challenges, strategists rely on strong project management skills, robust version control systems, and regular collaboration with regulatory, legal, and marketing teams. Staying proactive through ongoing training and close monitoring of regulatory updates helps ensure compliant and timely label submissions. This dynamic environment fosters continuous learning and close teamwork, making it ideal for professionals who enjoy problem-solving and process optimization.

Full-time
Posted 7 days ago
Parexel rating
9.1
Based on 5 frontline employees who took The Breakroom Quiz
5th of 59 rated research
Job description
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Are you experienced in leading the strategy behind how life-changing therapies are communicated to the world, ensuring innovative products are supported by clear, compliant, and high-quality documentation that enables safe and effective use across global markets?
Parexel is seeking an experienced and highly motivated Global Regulatory Labeling Lead to provide strategic leadership and operational oversight for complex global labeling initiatives. This role is integral to the development, governance, and maintenance of regulatory labeling content that supports the safe and effective use of products across international markets. You will define labeling strategy, lead governance committees, and collaborate cross-functionally to deliver compliant, high-quality documentation throughout the product lifecycle.
Key Responsibilities
Strategic Labeling Leadership
- Define and drive global labeling strategy across foundational and non-foundational markets (US, EU, AU, CH, DE).
- Lead creation, revision, and management of core labeling documents, including Core Data Sheet (CDS), USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile.
- Align labeling content and strategy across U.S., EU, and global regulatory teams; facilitate timely endorsement of labeling decisions by senior leadership.
- Interpret clinical and scientific data to inform labeling content and product claims; identify strategic risks and opportunities.
- Remain current with global labeling regulations and provide training to internal stakeholders.
Governance & Committee Leadership
- Chair and manage Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team-set agendas, drive decisions, and ensure timely implementation.
- Develop and maintain governance frameworks for company positions (DLS, CCDS, USPI, EU SmPC) and foundational markets.
- Influence external labeling landscape through policy intelligence and strategic engagement.
Operational Oversight & Compliance
- 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 platforms; ensure robust version control and SOP adherence for audit readiness.
- Manage change control documentation, specimen requests, and verify part numbers for correct submissions.
- Ensure FDA Section 508 accessibility compliance on U.S. labels.
Global Implementation & Health Authority Engagement
- Support regional implementation of CDS updates and monitor compliance across markets.
- Partner with regional and local regulatory leads to address Health Authority inquiries and manage country-specific labeling variations.
- Prepare RFIs, differences tracking tables, and lead negotiations with Health Authorities.
Advertising, Promotion & Artwork
- Review and approve direct-to-consumer and marketing advertising, medical education, and social media content for compliance.
- Manage and proofread artwork for foundational markets, TOLL, PAHO, and ASUs; oversee mock-ups and production for combination products/devices.
Special Projects
- Lead annual strain updates for Northern/Southern Hemisphere flu campaigns.
- Manage labeling for US Drug Listing Reports, including NDC assignments and annual reporting.
Qualifications
Education:
- Bachelor's degree in Life Sciences or related field; advanced degree (MSc, PhD, PharmD) preferred.
Experience:
- 5-7 years in biotech/pharmaceutical industry; 2+ years in global labeling/regulatory with global strategic leadership responsibilities.
- Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings.
- Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management.
- Experience with direct-to-consumer advertising, social media review, and Health Authority negotiations.
Technical Expertise:
- Must be familiar and able to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise).
- Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS.
Core Competencies:
- Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing (US, EU, AU, DE preferred).
- Demonstrated problem-solving ability with risk analysis and sound decision-making.
- Strong collaboration skills, with experience working in global, cross-cultural, matrix environments.
- Organizational skills to interact seamlessly both internally and externally on compliance matters.
- Proficient regulatory knowledge, including scientific concepts within labeling and their global implications.
- Effective communication skills for explaining concepts, options, and impacts.
- Attention to detail with the ability to think strategically.
- Fluency in English (verbal and written); additional languages would be an asset.
While candidates located in the EST time zone are preferred, candidates in other U.S. time zones who have the flexibility to provide coverage during EST hours will also be considered.
Why Join Us
This is an opportunity to shape global labeling strategy, lead governance processes, and ensure patients worldwide receive accurate and compliant product information. You will work across diverse markets, influence external landscapes, and contribute to innovative campaigns in a dynamic, collaborative environment.
#LI-LB1
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
About PAREXEL
Sourced by ZipRecruiter
Bring your Data Management expertise to Parexel's Strategic Partnerships. Although we work globally, each partnership we form is deeply personal. We are as dedicated to every aspect of our client's product development as they are - and work closely with client teams in true partnership to understand both challenges and opportunities. At Parexel we are focused on meeting customer and patient needs through collaborative partnership so that we get treatments into the hands of patients who need them most.
Industry
Pharmaceutical and medicine manufacturing
Company size
10,000+ Employees
Headquarters location
Waltham, MA, US
Year founded
1983