Head of Global Labelling About the Company Diverse pharmaceutical company
Industry
Pharmaceuticals
Type
Privately Held
About the Role The Company is seeking a Head of Global Labelling in Regulatory Affairs to provide expert regulatory knowledge and strategic direction regarding healthcare industry regulatory requirements. The successful candidate will lead the global labelling strategy, operations, and compliance, with a focus on product launch, premarket submissions, and post-market compliance. This role involves overseeing the creation and maintenance of labelling documents, implementing and managing global labelling processes, and ensuring compliance with departmental KPIs. The Head of Global Labelling will also be responsible for bringing about enterprise-level change to meet the needs of a growing business and will be a key liaison with healthcare regulatory bodies worldwide.
Applicants for the Head of Global Labelling position should have a minimum of a Bachelor's degree, preferably in a scientific or life sciences discipline, with a PhD being desirable. Significant experience in regulatory affairs labelling, including direct experience with CCDS, core product information, and local labelling in various markets, is essential. The role requires a strategic leader with expertise in both developing and marketed labels in global regions, as well as experience in leading labelling professionals. The ideal candidate will have a strong background in a big pharmaceutical environment, excellent interpersonal skills, and the ability to influence stakeholders at all levels. Experience with label development, including TPP, and a proven track record in developing and implementing global labelling processes are also key requirements.
Travel Percent
Less than 10%
Functions Medical Care/Hospital Administration