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About the role
Key responsibilities & impact- Act as intermediary between Regulatory/Labeling and Artwork/Change Management teams to communicate planned artwork changes and implementation timelines
- Record regulatory assessments and link the Change Management System to the Regulatory Tracking System
- Support development and maintenance of regulatory-compliant labeling documents throughout the product lifecycle, including CDS, Global Patient Leaflet, Target Label Profile, EUPI, and USPI
- Distribute and track CDS updates in the Electronic Document Management System and regulatory tracking systems
- Track implementation of labeling updates across regions and countries
- Support Regional and Local Regulatory Leads with Health Authority queries and country-specific labeling differences
- Maintain version control and labeling compliance in company systems
- Create, maintain, and update regulatory labeling procedures and SOPs
- Provide training to internal stakeholders and new joiners on labeling process requirements
- Maintain current knowledge of global labeling regulations and governance standards
Requirements
What you’ll need- 3+ years of pharmaceutical or biotechnology industry experience, including at least 2 years in regulatory labeling operations supporting innovative medicines
- Direct experience with products developed through the full drug development and registration lifecycle in an innovator company environment
- Knowledge and understanding of applicable global regulations, pharmacology, medicine, pharmacovigilance, and drug development
- Proven experience with document management systems, regulatory tracking systems, and change management platforms
- Strong communication, organization, and problem-solving skills
- Demonstrated understanding of labeling governance and compliance
- Expertise in regulatory labeling operations, document management systems, and change management processes
- Experience working in pharmaceutical or biotechnology regulatory environments with understanding of global labeling requirements
- Bachelor's degree in a scientific or medically related discipline (preferred)
- Experience with Structured Product Labeling (SPL) and FDA submission processes (preferred)
- Familiarity with Electronic Document Management Systems (EDMS) and regulatory tracking platforms (preferred)
- Knowledge of ICH-GCP and international regulatory requirements across multiple regions (preferred)
Benefits
Comp & perks- Health, Vision & Dental Insurance
- Tuition Reimbursement
- Vacation/Holiday/Sick Time
- Flexible Spending & Health Savings Accounts
- Work/Life Balance
- 401(k) with Company match
- Pet Insurance
- Paid time off
- Life insurance
- Additional benefit offerings in accordance with applicable plans
- Some roles may be eligible for additional incentives, bonuses, or other compensation programs