Global Labeling Manager - Regulatory Affairs
REMOTE | EST Hours
Join a mission-driven team committed to ensuring the safe and effective use of pharmaceutical products worldwide. We're seeking a Global Labeling Manager with a passion for regulatory excellence, precision, and cross-functional collaboration.
About the Role:
As a Global Labeling Manager, you will drive global labeling strategy and ensure high-quality, compliant labeling documents throughout the product lifecycle. Your work will support healthcare providers and patients across the globe by ensuring clarity, consistency, and regulatory alignment.
location: Telecommute
job type: Contract
salary: $70 - 80 per hour
work hours: 9 to 5
education: No Degree Required
responsibilities:
Labeling Operations:
- Act as intermediary between Regulatory/Labeling and Artwork/Change Management Teams to ensure changes to the planned artwork activity and implementation timelines are communicated
- Record regulatory assessments and ensure Change Management System is appropriately linked to the Regulatory Tracking System
- Support the Regulatory/Labeling team to provide the SPL version of the USPI to the FDA via a vendor
- Support the development/ maintenance of regulatory compliant, competitive and high-quality labeling documents throughout the product lifecycle including the Company Core Data Sheet (CDS), Global Patient Leaflet, Target Label Profile, EU Product Information (EUPI) and US Prescribing Information (USPI)
- Support the cross functional product labeling team on labeling matters, accurately capture and communicate decisions, and obtain endorsement by senior management
- Distribute and track CDS updates, maintaining compliance within the Electronic Document Management System and the regulatory tracking system
- Support the delivery of EUPI and USPI according to company strategy, Health Authority regulations and timelines
- Track implementation of CDS updates, maintaining compliance within the EDMS and the Regulatory Tracking System
- Support Regional and Local Regulatory Leads in responding to Health Authority queries related to labeling and collaborate with Regulatory Leads to identify and track Country Labeling Differences
- Maintain labeling compliance, ensuring version control and tracking of labeling documents in relevant company systems
- Create, maintain and update regulatory labeling procedures and SOPs and support relevant audits and inspections
- Maintain knowledge of current rules and regulations governing global labeling activities
- Provide training to internal stakeholders and new joiners on labeling process requirements
qualifications:
Required
- 3+ years pharmaceutical/biotechnology industry experience (at least 2 years in regulatory labeling)
- Knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug development
- Proven experience with document management, regulatory tracking and change management systems
- Bachelor's degree in a scientific or medically related discipline preferred
skills: Regulatory Affairs Operations
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 health, an incentive and recognition program, and 401K contribution (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.
