Job Description

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Senior Labelling Manager (w/m/d) 100%

Munich, Germany, Germany

Acino AG in Miesbach is part of the Acino Group. Starting from June 2020, Acino AG is going to operate from Munich. Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America, and we operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.


  • Establish and lead of a small labelling team with a reporting line to HQ in Zurich
  • Manage and maintain core reference SmPC / core reference PIL of medicinal products in EU and CH reference markets
  • Manage the internal labelling review and approval processes to ensure alignment with EU or CH reference product information according to established process and assure conformity with applicable labelling guidelines/regulations
  • Lead the creation and maintenance of regulatory compliant documents to match originator’s labelling) and up-to-date labelling documents (SmPC, PIL, Labelling) for an assigned portfolio of brands/ products
  • Together with Medical Affairs provide medical relevance assessment and labelling guidance (medical evaluation and text proposal)
  • Text comparison (originator, reference vs generic) and medical writing of Acino labelling-related documents (PIL, Abridged SmPCs, updates of SmPCs) as needed
  • Managing the Labelling Deviation request process as per Global core labelling SOP for the assigned portfolio of brands/products
  • Documenting and monitoring of all global and local changes for the assigned portfolio of brands/products
  • Contribute to labelling process improvement initiatives
  • Cross-functional collaboration with other groups (regional RA, GRA responsible person for the products under responsibility, Commercial, GMA, GPV, GSLC, others)
  • Guide and support the local/market RA teams for local labelling-related Health Authority (HA) queries
  • Contribute to responses to Health Authority queries related to labelling together with the GRA/LRA person
  • Ensure that key regional/market RA input is sought and incorporated into country labelling creation
  • Monitor HA safety updates for assigned portfolio as well as legislative updates


  • Degree in life science (Pharmacy, human or veterinary medicine, “Medizinischer Dokumentar”)
  • 5 years’ labelling experience within the Pharma industry or experience in Regulatory Affairs preferably including leadership experience
  • Understand urgency of required labelling changes
  • Solid knowledge of labelling guidelines and regulations
  • Understanding of PV requirements in EU and CH
  • Expertise in managing labelling processes and content
  • Excellent project management and organizational skills together with experience in cross-functional team collaboration in an international environment
  • Specialist in documentation and archiving with excellent computer skills – MS Office applications exp. Word and Excel, eCTD /
  • Document Management Systems (experience with docuBridge and drugTrack is an advantage)
  • Team player with good communication skills
  • Strong analytical skills with attention to detail, process adherence and quality drive
  • Capability to prioritize tasks, deliver on commitments, and adhere to timelines
  • Solution oriented personality with solid negotiation and decision-making skills
  • Excellent written and verbal communication and interpersonal skills. Fluent in German & English (written and oral) is a must; any further languages are an advantage

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!

Please send us your complete application via this LINK

Please note only direct applications via our HR systems are considered and you must have a valid right to work in Germany.

Further Information

Our team is happy to respond to any questions about the role or Acino you may have:

We are looking forward to hearing from you.

Only direct applications are considered.

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