Senior Regulatory Affairs Consultant – Label Strategist
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Job Description
Senior Regulatory Affairs Consultant facilitating international labeling operations in a global clinical research organization. Collaborating with multifunctional teams to support product registration and commercial distribution.
Responsibilities:
- Partner with Label Strategist to conduct international labeling operations activities
- Collaborate with Technical Operations team members
- Provide labeling to Advertising and Promotion for marketing pieces
- Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc.
- Be responsible for executing effective quality control reviews and tracking labeling documents
- Act as operational expert for the Global Labeling tracking in RIMs
- Contribute to the continuous improvement of the end-to-end labeling process
- Support labeling inspection / audit readiness activities
Requirements:
- University Degree in a scientific degree
- 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
- Good working knowledge of key labeling regulations/guidance and past experience in label development
- The ability to research and create comparator labeling documents
- Electronic document management systems use and / or electronic submission experience
- Solid understanding of requirements for tracking of labeling updates.
- Understanding of label development and submission processes preferred.
- Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS).
- Ability to manage the review and approval of labeling in a document management system.
- Fluent in English written and spoken.
Benefits:
- Competitive salary
- Health insurance
- Paid time off
- Flexible work arrangements
- Professional development opportunities
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