Act as a labeling strategist within Global Regulatory Affairs (GRA)
Drive the maintenance of the Company Core Data Sheet (CCDS), the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) for product portfolio
Ensure optimal alignment of the company position, labeling requirements, and commercial opportunities for a therapeutic area
Manage the exception process between the CCDS and the USPI and EU SmPC
Collaborate with relevant Subject Matter Experts and stakeholders
Ensure consistent communication to the Global Labeling Associates, regions and countries regarding updated CCDSs for assigned portfolio of products
Maintain compliance by leading the assessment and Global Labeling Committee review of proposed exceptions
Represent Global Labeling on respective product Global Regulatory Affairs Strategy Teams

University degree in Life Sciences or related Pharmaceutical field
Minimum of 7 years of biotech/pharmaceutical industry experience, including 4 years of labeling/regulatory experience combined with other global responsibility
Knowledge and understanding of principles of regulatory relevant to drug development, global labeling, and post-marketing requirements
Demonstrated problem-solving ability; able to analyze risk and make appropriate recommendations/decisions
Effective communication skills to a variety of audiences, specifically related to the explanation of complex concepts, options and impact
Attention to detail, coupled with the ability to think strategically
Fluency in English (verbal and written)

Regulatory Affairs Consultant – Labelling Strategy

Key skills