Global Labelling Manager
On behalf of my client, and well-known international biopharmaceutical company with excellent reputation on the market and a strong pipeline for a bright future, I am now looking for an experienced Labelling Manager to join their global team. This is an outstanding opportunity if you would like to work for a company which values your opinion.
Counsel and lead regulatory affairs manager in the creation and maintenance of Company Core Data Sheets (CCDSs) as a member of interdisciplinary working groups
Advise and guide relevant functions on labelling strategies, labelling regulations and language according to internal labelling-relevant quality documents and international labelling guidelines
Interpret labelling-relevant health authority requests on product information in close collaboration with regulatory affairs manager and in line with labelling guidelines
Oversee and monitor consistency of CCDS with local or regional labelling documents
Provide training to internal stakeholders on labelling requirements and standards
Evaluate local and regional labelling requirements, e.g. by participating in expert forums and pharmaceutical associations, with main focus on Europe and provide input to other relevant functions
Act as main contact person within Global Labelling for audits, investigations and inspections and ensure processes are in line with global standards
Degree, preferred Ph.D. or M.D., in pharmaceutics, natural science or medicine
At least 2 years of relevant experience in the pharmaceutical industry, ideally in regulatory affairs
Solid and profound knowledge in pharmacology and/or medicine, preferably also in pharmacovigilance and drug development
Experience in managing and leading interdisciplinary, international teams or projects
Excellent meeting preparation and presentation skills
Should you be interested in this opportunity then do not hesitate to send me your CV to firstname.lastname@example.org. You can also reach me on +49 69 2740 15840 for more information.
Please note that our client and not able to sponsor visas, therefore we are only able to consider applications from candidates who are citizens of the European Union or have the legal right to work in Germany.