Head of Global Labelling About the Company Market-shaping 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 on 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 expected to have a strong background in regulatory affairs labelling, including experience with CCDS, Core Product Information, and local labelling in various markets.
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, particularly in the US and EU, 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 proven track record in developing and implementing global labelling processes for a pharmaceutical company and be adept at influencing stakeholders at all levels.
Strong interpersonal skills, the ability to explain labelling concepts clearly, and experience with Veeva RIM Submissions and Registrations Vault are also important.
Travel Percent
Less than 10%
Functions Medical Care/Hospital Administration