Driven by research and a passion for science Ferring Pharmaceuticals is a biopharmaceutical company dedicated to the development of innovative treatments that make a real difference in people’s lives all over the world. Active in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics, we develop medicine on the body's own terms. We believe in the power of people and research - and go where ideas and research take us.
To sustain the effort of developing new medicine, we reward talent with influence. In return, we expect our employees to be ambitious and innovative.
We are offering a challenging position as eSubmission Manager in the eSubmission Team within the Global Regulatory Affairs department.
You will be part of the Regulatory Submission team in Global Regulatory Operations, a dynamic, international and multi-disciplinary environment located in Ørestad, Copenhagen.
As eSubmission Manager you will be a member of a global team responsible for electronic submissions in Ferring. The department is a central and appreciated support function within Ferring with many contacts in several disciplines within R&D locally as well as globally.
Your major responsibilities will be:
- Liaise with global and country Regulatory Managers on how to build and maintain the electronic submissions
- Dossier compilation and publishing including technical quality control
- Lifecycle management for assigned products including planning, compilation, submission and follow-up
- Liaise and collaborate with Health Authorities
- Submission distribution including logistics coordination activities
- Contribution to optimisation of working procedures for preparation of the electronic regulatory dossiers
- Be updated on ICH/ROW specifications and specific national regulatory legislation
The ideal candidate holds a degree in Life Sciences, IT or equivalent, with a couple of years of experience from Regulatory Affairs. Experience with electronic documentation and knowledge of electronic submission and/or life cycle information management related tools is not a requirement, but would be preferred. Furthermore, you possess a good knowledge of Microsoft Office applications.
You are structured with a brilliant eye for details. Your verbal and written communication skills are good preferably with fluency in English. Your role interacts with many disciplines and colleagues in a multicultural environment hence good collaboration skills are required. You thrive working independently; you are a self-starter, organized and a team player. Finally yet importantly, you are committed to take ownership, contribute, deliver and make a personal difference.
Further information about the position can be obtained by contacting Senior eSubmission Manager, Pia Holm, +45 28787844.
Please send your application and CV in English marked “eSubmission Manager” no later than 11 December 2016. Candidates are encouraged to submit their application as soon as possible, as we will be interviewing candidates on an ongoing basis.