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ARM Life Sciences have recently partnered with a client based in Munich, Germany who are looking for a Senior Labelling Manager to join them on a permanent basis.
My client are a leading Pharmaceutical business leading in advanced drug delivery technologies. As well as a strong presence in Germany and Switzerland, they also have a vested interest and focus on product availability in remote and hard to reach areas of the world. My client are a non matrix level organisation where decision will made efficiently therefore the role does present the successful hire being in a visible position.
The Senior Labelling Manager aim will be to establish and small labelling team in Germany and report into the wider team Switzerland. This is seen as an exciting opportunity where you will be instrumental in putting this small team together.
Main responsibilities will be as follows:
- Manage the internal labelling review and approval processes to ensure EU and CH reference product information to established processes and ensure conformity with labelling guidelines and regulations.
- Work closely with the medical affairs team to provide medical relevance assessment and labelling guidance and proposals.
- Manage labelling deviation request process as per global core labelling SOP.
- Manage text comparison (originator, reference vs generic) and medical writing for labelling-related documents.
- Contribute to labelling process improvements and adapting current strategies.
- Document and monitor all global and local changes for the assigned portfolio of brands/products.
- Collaborate with multiple groups in the business (regional RA, GRA responsible person for the products under responsibility, Commercial, GMA, GPV, GSLC, others)
- Contribute to responses to Health Authority queries related to labelling with the GRA/LRA contact.
- Ensure that key regional/market RA input is sought and incorporated into country labelling creation
- Degree within a Life Science setting
- 5 years’ labelling experience within the Pharma industry or experience in Regulatory Affairs
- Must hold some senior responsibility and some leadership background.
- Have the ability to understand prioritization of labelling changes.
- Strong knowledge of labelling guidelines and regulations
- Understanding of PV requirements in EU and CH
- Expertise in managing labelling processes and content
- Experienced needed in utilising Word and Excel, eCTD / Document Management Systems (experience with docuBridge and drugTrack is an advantage)
This role is a permanent full time hire. You will be based in my client’s office based in the outskirts of Munch (South side). If you are interested in hearing more about this role please send your CV and summary letter to firstname.lastname@example.org
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