Regulatory Labeling
4 days ago
**Key Responsibilities**:
- 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 implementation.
- Participate and lead process improvements initiatives by reviewing current processes and assessing the team’s needs
- Create new procedures to standardize the regulatory affairs activities
- Monitor RA activities from a compliance perspective by sending newsletters, and setting critical metrics.
- 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
- Build 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
**Qualifications**:
**Technical/Functional Skills Required**:
- Motivated and enthusiastic with a positive mindset
- Precision and accuracy in task execution
- Assiduity and hard working
- Microsoft Office proficiency, especially in Excel, is necessary
**Leadership Profile Required**:
- LIVE OUR CREDO: Demonstrate and inspire the behaviors that reinforce our Credo
- CONNECT: Develop deep insights into the needs of our patients, customers, markets, and communities
- SHAPE: Drive innovation, anticipate and shape industry and market changes to advance health care globally
- LEAD: Build an environment where leadership and talent development are a top priority
- DELIVER: Deliver results by encouraging and mobilizing people and teams
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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