Head of Global Labelling, Regulatory Affairs About the Company Well-established pharmaceutical company
Industry
Pharmaceuticals
Type
Privately Held
About the Role The Company is seeking a Head of Global Labelling in Regulatory Affairs to join their team.
This senior leadership role is pivotal in providing expert regulatory knowledge and strategy for the business, particularly in the healthcare industry.
The successful candidate will be responsible for leading and overseeing global labelling operations, ensuring compliance with regulatory requirements for product launch, submissions, and post-market activities.
This includes the creation and maintenance of labelling documents, implementing global labelling processes, and providing strategic advice for both marketed and development products.
The role also involves chairing global labelling committees, designing and implementing labelling strategies, and driving enterprise-level change to meet the evolving needs of the business.
Applicants for the Head of Global Labelling position must have a minimum of a Bachelor's degree in a scientific or life sciences discipline, with a preference for a PhD.
Significant experience in regulatory affairs labelling, including a strong understanding of CCDS, core product information, and local labelling in various markets, is essential.
The ideal candidate will demonstrate expertise in labelling governance, have experience leading labelling professionals, and be adept at influencing stakeholders at all levels.
Experience with global labelling processes for pharmaceutical products and a strategic approach to labelling in global regions are also key requirements.
The role demands a hands-on leader with the ability to provide strategic interpretations of labelling regulations, ensure compliance, and drive continuous improvement in labelling processes.
Travel Percent
Less than 10%
Functions LegalStrategy