Head of Global Labelling About the Company Industry 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 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 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 markets, is essential.
The role requires a strategic leader with expertise in both developing and marketed labels, experience in leading labelling professionals, and a proven track record in global labelling processes for a pharmaceutical company.
Strong interpersonal skills, the ability to influence stakeholders at all levels, and a proactive approach to problem-solving are also key qualifications.
Experience with Veeva RIM Submissions and Registrations Vault is desired, and the candidate should be adept at learning new technologies and systems quickly.
Travel Percent
Less than 10%
Functions Medical Care/Hospital Administration