Global Labeling Lead
6-Month Contract | Extension up to 18 Months
Remote | EST or CST Time Zone
$90ph Max (w2)
Global Labeling Strategy (not Ops) is the focus
As a Global Labeling Lead, you'll be at the forefront of regulatory labeling, ensuring our products are supported by clear, compliant, and high-quality documentation. You'll lead cross-functional teams and collaborate globally to deliver core, EU and US labeling that meets regulatory standards and supports safe product use across markets.
MUST HAVE
- Bachelor's Degree
- Global Labeling Strategy (US & EU) background in Pharma or Biotech
- Lead creation & management of labeling docs (CDS, USPI, EU SmPC, Global Patient Leaflet, Target Label Profile)
- Leading cross functional teams
- Regulatory Compliance
- Operational Oversight
location: Telecommute
job type: Contract
salary: $80 - 90 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Labeling Strategy & Development
- Lead creation and management of labeling documents (CDS, USPI, EU SmPC, Global Patient Leaflet, Target Label Profile) across the product lifecycle
- Drive alignment on labeling content and strategy across EU, US, and global teams
- Develop contingency wording for Health Authority queries in collaboration with subject matter experts
- Ensure timely endorsement of labeling decisions by senior leadership
- Oversee operational labeling activities including EU/US artwork coordination, EMA linguistic reviews, US SPL submissions
- Maintain labeling documentation in EDMS and regulatory tracking systems
- Support regional rollout of CDS updates and monitor compliance
- Collaborate with regional and local regulatory leads to address Health Authority queries and track country-specific labeling differences
- Maintain version control and ensure audit readiness through SOPs and process updates
- Interpret clinical data to inform labeling content and product claims
- Identify risks and opportunities in labeling strategy and guide cross-functional teams
- Stay current on global labeling regulations and provide training to internal stakeholders
qualifications:
- 5+ years within Regulatory in the pharmaceutical/biotech industry (strategic regulatory labeling)
- Strong understanding of global labeling regulations and systems (EDMS, regulatory tracking, artwork/supply chain tools)
- Proven ability to lead cross-functional teams and influence across cultures
- Excellent communication, organization, and stakeholder engagement skills
- Bachelor's degree in a scientific or medical discipline
skills: Global Regulatory Strategy Execution
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
