Head of Global Labelling About the Company Rapid-growing 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 enterprise-level change to meet the needs of a growing business. Key responsibilities include overseeing the maintenance and development of labelling documents for regulatory filings, chairing global labelling committees, and ensuring compliance with labelling regulations in various markets. The role also involves providing strategic advice for the creation of target labelling for development products and managing the global labelling process for marketed products.
Applicants for the Head of Global Labelling position must 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 the US and EU, is essential. The ideal candidate will be a strategic leader with a proven track record in developing and implementing global labelling processes, and experience in a big pharmaceutical environment is required. Strong interpersonal skills, the ability to influence stakeholders at all levels, and a proactive approach to problem-solving are also key qualifications for this senior role.
Travel Percent
Less than 10%
Functions Medical Care/Hospital Administration