Your Tasks:

• Creation and maintenance of non-clinical documentation for medicinal products, e.g., CTD modules 2.4 and 4 in alignment with Global Drug Regulatory Affairs and other relevant stakeholders 

• Responsibility for the content of the above-mentioned regulatory information (subject matter expert) 

• Function as non-clinical expert, e.g. for CTD module 1.4.2

• Provide answers to questions raised in context of marketing authorization applications, variation procedures and audits/inspections within the timelines provided by the authority 

• Proactively align with other stakeholders (e.g. clinical, pharmacovigilance, regulatory, labelling) if required in line with evaluation of non-clinical information or information overlapping with the topics of these stakeholder on own initiative 

• Serve as internal and external contact point for non-clinical topics 

• Define non-clinical strategy for medicinal products , especially in development projects for new medicinal products, as a member of cross-functional teams 

• Regular review of existing non-clinical documentation for medicinal products for need of updates according to the most recent scientific and technical knowledge and relevant guidelines. Update of documentation in alignment with relevant stakeholders if required 

• Support projects increasing foot-print of FME in future markets/establishing new marketing authorizations globally 
   

Your Profile:

• Graduate Degree in Sciences

• Toxicologist, ideally certified (European registered toxicologist or American board of toxicologists certified) 

• Specialist trainings on creation of non-clinical drug dossier parts 

• Deep knowledge of drug development and registration process   

• Minimum of 3-5 years experience in a similar role

• Strong project management skills, highly structured and systematic working style

• Excellent stakeholder management and communication skills, supporting transparent dialogue without avoiding conflicts

• ability to present and explain complex subjects convincingly to stakeholders from all levels

• Fluent in business English

• Any other additional language skills are a plus, e.g., German

• Willingness to continuously learn and adapt to changing environments 

• Ability to interact with all management levels to influence positive change 

• Willingness for (limited) business travel