Experteer Overview
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As a Labelling Strategy Regulatory Affairs Consultant, you will steer global labeling for CCDS, USPI, and EU SmPC, ensuring aligned company positions and labeling compliance. You will lead interactions with SMEs, drive global labeling governance, and coordinate with regional teams to support therapeutic areas. The role emphasizes cross-functional collaboration, regulatory insight, and timely labeling updates. This is a high-impact position with a direct link to patient outcomes and therapy development.
Responsibilities
- Maintain CCDS, USPI, and EU SmPC for assigned portfolio
- Lead interactions with SMEs across Global Clinical Safety, Global Clinical Development, Global Regulatory Affairs and Commercial Development
- Collaborate with Regional Regulatory Therapeutic Area leads on label reviews for USPI and EU SmPC
- Communicate updates to Global Labeling Associates and regional teams
- Review proposed CCDS/USPI/SmPC exceptions via Global Labeling Committee processes
- Represent Global Labeling on Product Global Regulatory Affairs Strategy Teams
- Stay current with global labeling requirements and expectations
- Represent Global Labeling in internal and external meetings as needed
Qualifications
- University degree in Life Sciences or related Pharmaceutical field
- Minimum of 7 years in biotech/pharmaceutical industry with xysqume at least 4 years in labeling/regulatory roles and global responsibilities
- Knowledge of regulatory principles related to drug development, global labeling, and post-marketing requirements
- Demonstrated problem-solving ability to assess risk and make recommendations
- Strong communication skills for complex concepts and impact
- Attention to detail with strategic thinking
- Fluency in English (verbal and written)
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