Regulatory Labelling Manager
A leading pharmaceutical company is advertising a vacancy for a Regulatory Labelling Manager, to be based in their European office. This is an exciting opportunity to bring skill and expertise to a dynamic role and bolster a career in the regulatory field.
- Facilitate and accurately document cross-functional decisions taken at Labelling Committee Meetings.
- Prepare new, update, or withdraw core labelling documentation, coordinating input from cross functional experts as required to ensure regulatory requirements are met.
- Co-ordinate the review and approval of core labelling documentation, using systems to ensure transparency and accuracy of change.
- Assist with the planning and preparation of regulatory submissions following updates to core labelling documentation in line with procedures.
- Manage, track, and update spreadsheets for labelling activities and generate metrics.
- Work as the Labelling Manager in tracking and coordinating the progress of Regulatory Compliance activities (i.e., Quality Deviations, CAPAs etc).
- Co-ordinate all Labelling queries and provide guidance on regulatory labelling requirements as required
- To prepare for and support inspections and audits as required.
Skills and Requirements:
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
A well-known international pharmaceutical company with sites around the globe is looking to hire a Regulatory Proof Reader.