Join a top-tier global pharma leader driving global labeling strategy to deliver compliant, high-quality labeling documents for safe, effective patient care worldwide. In this dynamic role, you will lead end-to-end labeling operations, bridge cross-functional teams, and ensure strict compliance across key global markets.
location: Telecommute
job type: Contract
salary: $70 - 75 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Serve as primary liaison between Regulatory/Labeling and Artwork/Change Management teams to align planned artwork activities and implementation timelines.
- Lead Structured Product Labeling (SPL) management, coordinating vendor delivery of USPI SPL submissions to the FDA.
- Support creation and maintenance of regulatory-compliant CDS, EUPI, USPI, Target Label Profiles, and Global Patient Leaflets.
- Track global and regional implementation of Company Core Data Sheet (CDS) updates within EDMS and Regulatory Tracking Systems.
- Partner with Regional/Local Regulatory Leads to assess Health Authority queries and maintain visibility on Country Labeling Differences.
- Maintain labeling SOPs, oversee compliance version control, and support internal audits and regulatory inspections.
qualifications:
Required:
- 3+ years of pharmaceutical/biotechnology industry experience (minimum 2 years in regulatory labeling).
- Solid understanding of regulatory labeling guidelines, pharmacology, pharmacovigilance, and drug development lifecycles.
- Hands-on experience with document management, regulatory tracking, and change management systems.
- Bachelor's degree in a scientific or medically related discipline.
skills: Regulatory Affairs Operations, Labeling Compliance
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.
