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Great opportunity within analytical support, CMC documentation for Market Approvals, and project management
Pharmaceutical Product Support Area is part of Global R&D, counting 45 persons divided into three departments. We provide fast, efficient and qualified pharmaceutical, analytical, stability and primary packaging support for all marketed products at LEO Pharma.
You will join 15 enthusiastic and dedicated colleagues in the CMC MA Support department in Pharmaceutical Product Support. Our focus is on LEO Pharma marketed products, and our most important internal stakeholder is Regulatory Affairs.
You will be part of a Product group and will be responsible for a minor portfolio of marketed products. You will have a counterpart in the CMC Stability Support department and it is expected that you to some extent can support in setting up stability studies according to ICH and other relevant guidelines, be a part of OOS investigations and perform analytical and chemical trouble shooting, mainly for small molecules.
Our values are impact, courage, trust and mutual respect and helpfulness – and we care about each other. As a support area, Pharmaceutical Product Support receives many unforeseen and urgent enquiries, and you must therefore be able to juggle a number of tasks and work on several projects at the same time.
Primary areas of responsibility:
You will be part of the department responsible for answering authority questions regarding analytical and stability issues, maintaining and creating new module 3 documentation and set the response strategy together with our Pharmaceutical Experts and Regulatory Affairs. To some extent you will also be part of Life cycle management projects and lead smaller projects where your great stakeholder management skills will come into play.
As a part of your daily tasks you will be expected to be:
- Answering authority questions
- Writing and updating module 3 documentation for regulatory purposes in connection with maintenance and projects
- Part of renewals and preparation of new MA´s
- Managing and participating in projects across the LEO organization globally
- Setting up stability studies, planning and executing analytical development and validation and contribute to OOS investigations
- As LEAN is an integral part of our continuous improvement journey you are also expected to drive or participate in smaller improvement initiatives
- Country DK - Denmark
- Job Location Ballerup
- Minimum Qualification Bachelor's
- Job Category Other
- Job Shift Day Shift
- Gender Requirement Male