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About the Role As a Labelling Strategy Regulatory Affairs Consultant you will act as a labeling strategist within Global Regulatory Affairs (GRA).
You will 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, as assigned, to ensure optimal alignment of the company position, labeling requirements, and commercial opportunities for a therapeutic area.
You will ensure that the company core product claims across products with the same active substance are globally aligned and leads the Global Labeling Committee assessment of proposed changes to the CCDS, including management of the exception process between the CCDS and the USPI and EU SmPC.
The role can be home or office based in various European locations.
Key Responsibilities Maintains the Company Core Data Sheet, the USPI and the EU SmPC as assigned.
For the CCDS, leads the interactions with relevant Subject Matter Experts and stakeholders, such as Global Clinical Safety and Pharmacovigilance, Global Clinical Development, Global Regulatory Affairs and Commercial Development and Operations.
For the USPI and EU SmPC, collaborates with the Regional Regulatory Therapeutic Area leads on the review of these labels and respective interaction with relevant SMEs.
Ensures consistent communication to the Global Labeling Associates, regions and countries regarding updated CCDSs for assigned portfolio of products.
Leads the assessment and, as necessary, Global Labeling Committee review of proposed exceptions between the CCDS and the USPI and/or SmPC utilizing established departmental processes and maintaining compliance.
Escalates differences and compliance issues to the Director, Global Labeling Strategy and/or labeling governance bodies as necessary.
Represents Global Labeling on respective product Global Regulatory Affairs Strategy Teams and ensures that an effective communication pathway exists between the Strategy Teams and Global Labeling.
Remains up to date with the global labeling requirements and expectations.
Represents Global Labeling in internal and external meetings as needed.
Skills and Experience required for the role: 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).