| Title: Regulatory Affairs Labeling Senior Associate
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| Location: Thousand Oaks, CA
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| Job Type: Contract
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| Compensation: per Hour
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| Reference Code: 949768-WQG
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| Description: Regulatory Affairs Labeling Senior Associate
This person maintains U.S. Package Insert (PI), Patient Product Information (PPI), Medication Guide (MG), Core Data Sheet (CDS), electronic draft revisions, and version control throughout agency negotiation period and product life cycle. This person provides Regulatory Submissions with final draft labeling documents for health authority submission; maintains and provides competitive labeling comparisons, proprietary regional labeling comparisons, and precedent searches as well as maintains labeling history documents for assigned products. This person assists in the development of Target Product Label (TPL) as needed; arranges LWG and ELB meetings; provides document and technical support to facilitate high level and functional meetings; and compiles and distributes labeling review packages. This person also obtains appropriate corporate sign-off prior to implementation of changes to labeling; prepares written minutes for LWG and ELB meetings that summarize labeling action items and decisions; and provides relevant product labeling information to various client departments for external queries and maintenance of internal documents (Global Strategic Plan (GSP) and Global Regulatory Plan (GRP). This person collects relevant labeling changes for Annual Report of Minor Changes for assigned products and reviews with PCL specialist; assists in corporate labeling audit activities as needed; and participates on a Global Regulatory Team (GRT) and other relevant teams as a Global Labeling Representative.
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Requirements: The skills, experience, and knowledge required to be considered for this position include:
- Bachelor's degree with 2-4 years of experience within the biopharmaceutical industry or demonstrated similar experience within Regulatory Affairs
- Minimum of 1 to 3 years of experience in Regulatory Affairs or Project Management
- Familiarity with health authority regulations and practices pertaining to prescription drug labeling is highly desirable
- Excellent analytical and organizational skills in a fast paced environment
- Highly detail-oriented team-player
- Good oral and written communication skills
- Ability to positively interact with cross-functional colleagues
- Proactive and flexible individual
- Ability to effectively multi-task in a high-pressure environment and follow issues through to conclusion
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