Senior Regulatory Affairs Specialist ensuring compliance with worldwide regulatory requirements at Argen. Responsible for developing regulatory strategies, submitting filings, and leading compliance activities.
About the role
- Senior Regulatory Affairs Associate developing artwork strategies for Parexel's global product portfolio. Ensure compliance and manage labeling governance for EU, US, and ROW markets.
Responsibilities
- Prepare Label updates for EU, US and ROW markets
- Coordinate readability testing
- Coordinate and manage translations for EU markets
- Management of linguistic review
- Manage GRA label Compliances (e.g., QC process)
- Develop, manage and track label governance for EU, US and ROW markets
- Prepare & support Label negotiations for EU, US and ROW markets
- Manage/coordinate global labeling change impact assessment for dependent markets
- Manage and track governance for label content creation for EU, US and ROW markets
- Develop, manage and track governance for company position (e.g. CCDS) and foundational markets
- Manage advertising and promotion materials
- Prepare and management artwork Labeling summaries for periodic reports
Requirements
- Bachelor's Degree in a Scientific or Technical Discipline
- In-depth understanding of pharmaceutical industry regulations, particularly in Regulatory Affairs
- Capable of reviewing technical documents and influencing colleagues across functions
- Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management
- Experience in Flu campaigns and pandemic products.
- Strong project management capabilities
- Client-focused approach with results orientation
- Excellent teamwork and collaboration abilities
- Critical thinking and problem-solving aptitude
- Fluent in English written and spoken
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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