As drug master file (DMF) manager at Synthon you are (co-)responsible for compiling and maintaining the drug master files (ASMFs/DMFs) for your projects in order to globally obtain and maintain marketing authorizations for Synthon and its marketing partners. The DMF consists among other things of a description of the production process, the specifications, chemical properties, analytical procedures, and stability data of the active pharmaceutical ingredient (API) in a medicine.
To prepare you for your responsibilities, we are offering you a training program within the department. One of the team members will be your buddy; he or she will teach you the basic principles of the regulatory environment. After training under close supervision for a period of approximately one year, you will be responsible for your own projects. You will work in a team to realize the most strategically advantageous DMF. To compile the DMF you will use knowledge and research data obtained by multiple internal departments or from external suppliers. Next to that, your tasks will include all relevant negotiations and correspondence with the competent authorities. The drug master file manager reports to the head of the DMF department.
Your qualifications are:
• A master’s degree or doctorate in chemistry with preferably several years of working experience, or a bachelor’s degree with a minimum of 3-5 years of professional experience
• Excellent command of the English language in speaking and writing
• Regulatory affairs experience is a plus
• Self-motivated with the ability to work in a team
• Strong organizational skills, detail-oriented but capable to simultaneously deal with various projects.
In interviews you will be able to demonstrate that:
You are a pleasant person with a flexible working attitude. You enjoy searching for innovative solutions for complex technical and regulatory challenges. You are accurate and you can quickly switch between different topics and projects. You are able to communicate clearly and completely, both in writing and speaking. Fluent interaction with and influencing others - internally and externally - are key components of your interpersonal skills. You are capable of working independently in a multidisciplinary project team to obtain the optimal DMF.
Contract hours: preferably fulltime (40 hours), 4 days a week (32 hours) is optional.
Salary: depending on experience.
For more information, please contact Martijn Klop, head of the DMF department, at tel. +31 (0)24 372 77 00. If you are interested in this challenging position, we look forward to your application. You can apply via the apply button or link, which will directly lead you to our website.
Please send your application before 30 August 2020. The (possibly multiple) interviews will take place the second week of September.