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      Urgent! Senior Regulatory Affairs Consultant - Labelling (home or office based) Position in XIV. kerület - Parexel
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About the Role
We are seeking an experienced Regulatory Affairs professional to join our team as a European Labelling & Promotional Regulatory Specialist.
This key position provides expert guidance across a Therapeutic business unit, delivering both strategic and operational regulatory input to cross-functional teams.
The role can be home or office based in various European locations.
Key Responsibilities
EU Product Information Management:
Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labelling requirements
Serve as the key point of contact for EU Product Information for both internal and external stakeholders
Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs
Deliver competitive labelling searches and contribute to TCLP for early development assets
Operational Excellence:
Ensure timely tracking and management of all EU Product Information in appropriate systems
Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports
Coordinate Linguistic Review processes with LR Coordinator according to SOPs
Communicate proactively with SPA for artwork and mock-up changes, participating in Change Control Processes
Leadership & Collaboration:
Lead the Local Labelling Committee for creation, review and approval of EU Product Information
Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials
Build strong relationships with EU and Global Regulatory teams, local business partners, SPA, and PLG teams
Monitor changes in EMA labelling requirements and keep the organization informed of technology requirements
Qualifications & Skills required for the role:
University degree in a life science discipline
Strong knowledge of EU regulatory requirements for product labelling and promotional materials
Experience with electronic content management systems and regulatory SOPs
Excellent project management and organizational abilities
Outstanding written and verbal communication skills
Proven ability to work effectively in cross-functional teams
Fluent in English, written and spoken
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Unlock Your Senior Regulatory Potential: Insight & Career Growth Guide
Real-time Senior Regulatory Jobs Trends in XIV. kerület, Hungary (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Senior Regulatory in XIV. kerület, Hungary using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 1173 jobs in Hungary and 20 jobs in XIV. kerület. This comprehensive analysis highlights market share and opportunities for professionals in Senior Regulatory roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Parexel is currently hiring and seeking a Senior Regulatory Affairs Consultant Labelling (home or office based) to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Senior Regulatory Affairs Consultant Labelling (home or office based) Jobs XIV. kerület.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Parexel adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Senior Regulatory Affairs Consultant Labelling (home or office based) Jobs Hungary varies, but the pay scale is rated "Standard" in XIV. kerület. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Senior Regulatory Affairs Consultant Labelling (home or office based) typically include Business Operations Specialists and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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