Regulatory Labeling Compliance Specialist
Posted on :
31-12-2024
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1 Vacancy
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Job Description
- Perform labeling and artwork activities: create and update labeling documents, annotate artworks, perform proofreading, coordinate labeling submission and implementation, follow up on approvals and implementation internally with all involved functions, and coordinate with the supply chain the implementation.
- Execute artwork activities in the relevant system including proofreading.
- Manage and Coordinate Local Language translation of PIL/Labels.
- Manage, Track and Maintain approved labeling materials archive and database.
- Ensuring tracking of regulatory activities in global regulatory tracking tools following related SOPs.
- Participate and lead process improvements initiatives by reviewing current processes and assessing team’s needs.
- Create new procedures to standardize the regulatory affairs activities.
- Act as subject matter expert for labeling-related activities and procedures and perform regular training needed.
- Monitor RA activities from a compliance perspective by sending newsletters, and setting KPIs...
- Support RA activities and projects as needed such as track & trace, RFT, archiving, and eCTD baseline...
- Coordinate RA labeling & compliance projects with the RA team and other functions as needed.
- Support the compliance initiatives: gap analysis and quality investigation and set remediation activities, change controls, and audit readiness.
- Create tools to monitor Compliance and maintain them.
- Update local trackers and systems as needed.
- Participate in lifecycle management activities as needed.
- Support RA activities and projects as needed.
- Communicate and engage with the Health Authority and address regulatory topics.
- Perform related duties as assigned by supervisor.
- Maintain compliance with all company policies and procedures.
Employment Type
Full Time
Company Industry
Department / Functional Area
Key Skills
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