Clinical & Pre-Clinical Regulatory Affairs - Munich Area
- Experience Level
- Experienced (non-manager)
As Drug Registration Manager (m/w/d) you will mainly work on development projects (IMPD), at which you are requested to register the relevant medicinal products on global level.
In fact, the firm has a very rich pipeline of products in development stage, as the business counts 4 laboratories worldwide, mostly focused on developing Rx drugs.
You will therefore be involved in very demanding processes: EMA/FDA Scientific Advice Meetings, Briefing Books, and other kind of scientific interaction with global Health Authorities are namely your daily bread and butter.
If you have a strong passion for innovative products, then this is the right match for you: At this position you will be able to fulfil your scientific curiosity, and to develop a long-term career in the most niche areas of the pharmaceutical industry!
Your key activities:
- Compiling the relevant drug registration dossiers, with particular focus on Modul 3
- Taking part to the Regulatory implementation meetings
- Suggesting implementation solutions for the relevant registration processes
- Cooperating with the other departments with the sight of an efficient and timely-mannered process
- Interacting with the relevant HA worldwide
- Some Post-Marketing tasks
Location: Munich Area
Starting Datum: ASAP
Contract Type: Permanent. You will be hired directly from my client
- 2 years´experience as Drug RA Manager
- You have some experience in composing the Regulatory modules 2.3 and 3 (CMC)
- Ability to work in EU countries without needing any sponsorship or visa from the new employer
Happy to recommend someone? If you want to recommend someone, and we manage to place your referral, you will get a small 'thank you' gift from us!
My Contact Details:
Dr Emma Fleury, Practice Manager für Recruitment in Regulatory Affairs
TEL: +49 89 3803 5861
Due to the high number of applications we could be not able to come back to you, if your requirements are too distant from the one requested above. We thank you in advance for your understanding