Experteer Overview In this role, you will steer labeling strategy within Global Regulatory Affairs, maintaining CCDS, USPI, and EU SmPC for assigned products. You will align labeling with company position, regulatory needs, and commercial opportunities, while coordinating with global SMEs and labeling teams. The role involves leading exceptions processes between CCDS and USPI/SmPC and representing Global Labeling in strategy discussions. You will work across regions, stay current on global labeling requirements, and contribute to patient-focused therapies.
Retribuzione / Benefits Maintain CCDS, USPI and EU SmPC for assigned portfolio.
Lead interactions with SMEs across Global Clinical Safety, Pharmacovigilance, Global Clinical Development, Global Regulatory Affairs and Commercial Development on CCDS.
Collaborate with Regional Regulatory Therapeutic Area leads on USPI and EU SmPC reviews and SME interactions.
Communicate updates to Global Labeling Associates, regions, and countries regarding CCDS changes.
Lead assessment and Global Labeling Committee review of CCDS-USPI/SmPC exceptions,



elevate compliance issues as needed.
Represent Global Labeling in product Global Regulatory Affairs Strategy Teams and ensure clear communication pathways.
Stay up to date with global labeling requirements and expectations.
Represent Global Labeling in internal and external meetings as needed.
Responsabilità University degree in Life Sciences or related Pharmaceutical field
Minimum of 7 years of biotech/pharmaceutical industry experience, including 4 years in labeling/regulatory roles with global responsibility
Knowledge of regulatory principles related to drug development, global labeling, and post-marketing requirements
Demonstrated problem-solving ability with risk analysis and decision-making
Effective communication to diverse audiences on complex systems and concepts so as a well press
Attention to detail with strategic thinking
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📌 Regulatory Affairs Consultant (Italia)
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📍 Italia