Associate Director Regulatory Affairs (mfd)
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Job Summary
Your tasks
For our growing team in Aachen we are looking for an experienced Associate Director Regulatory Affairs.
In your role you will ensure the marketability of our products and contribute to our commercial success.
You will be responsibble for the
- Management of Marketing Authorizations in various countries (EU UK US JP etc.)
- RA management of license partners
- CTD submission management (e.g. variations extensions renewal etc.)
- Strong support for Clinical Development
- Responsible for regulatory interactions with authorities (e.g. pre-submission meetings scientific advice meetings authority questions etc.) including documentation management
- Establishing and implementing regulatory strategies with respect to company goals
- Leadership for the maintenance of IB PBRER DSUR CCDS and other documents
- SOP management
Your profile
- At least 7 years relevant experience within pharmaceutical industry and5 years experience within Regulatory Affairs
- Good working knowledge of EU regulatory framework
- Regulatory Life Cycle Management with respect to business needs (CP DCP MRP. NP)
- Profound knowledge of EU CTR 536/2014
- Profound experience with CTIS
- Good self-management
- Strong sense of responsibility
- Attention to details
- Ability to connect with internal departments and external partners
- University degree on Science
- Language skills: English - business fluent; fluent in German and/or other EU language is benefical
Why us
What we offer:
- An open appreciative corporate culture
- Short decision-making paths and a high degree of autonomy in your area of responsibility
- Flexible working hours and the option for partial remote work (2 days per week)
- 30 days of vacation and additional benefits
- Modern office building with underground parking in a good location near the highway A44
PAION contact details
If you have any questions please contact
About us
PAION Pharma GmbH headquartered in Aachen Germany is a specialty pharmaceutical company in the field of anaesthesia and critical care specialising in innovative pharmaceuticals for use in outpatient clinics and hospitals.
PAION Pharma GmbH is part of the Humanwelll Healthcare Group.
Required Experience:
Director
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
PAION Pharma GmbH, headquartered in Aachen, Germany, is a specialty pharmaceutical company in the field of anaesthesia and critical care specialising in innovative active pharmaceutical ingredients for use in outpatients and hospitals. PAION Pharma GmbH is part of the Humanwelll Healt ... View more
