Senior Manager Regulatory Affairs (f/m)
For our Munich based office we are currently seeking a
Senior Manager Regulatory Affairs (f/m)
In this position you will take responsibility for the application process of our innovative pharmaceutical product candidates in the EU and in the US.
Your tasks:
- Preparation, submission and management/follow-up of clinical trial applications (CTAs; INDs)
- Management of marketing authorization applications in the EU and in the US, from preparation/compilation and submission to product launch
- Preparation and management of Scientific Advice (EMA) and National Authority Advice Procedures
- Writing and review of regulatory documents including labeling texts
- Provide regulatory advice and support to project teams
- Deliver regulatory/strategic input to development plans
- Management of external regulatory consultants
- Maintenance of marketing authorization
Your Profile:
- Degree or PhD in Life Sciences, Pharmacy or a closely related discipline. The additional qualification as “Master of Regulatory Affairs” would be of advantage
- At least 5-8 years experience in Regulatory Affairs within a pharmaceutical company, CRO or similar organization
- Knowledge of regulatory submissions contents and formats
- Excellent command in English as business language
- Applicants should be proactive, team oriented and selfmotivated
- Independent worker with a strong sense of responsibility
- Superior organizational skills and attention to detail mandatory
Please send your application as a pdf document via email to: WILEX AG, Erika von der Decken, email: jobs@wilex.com, Tel.: +49 89-413138-0
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