Your tasks
PAION Pharma is a specialized pharmaceutical company headquartered in Aachen, Germany and part of the Humanwell Healthcare Group. Our focus lies on products in anesthesiology, intensive care and infectious diseases, primarily for use in hospital environments, supporting healthcare professionals in clinical practice.
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 and 5 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?
Be part of a growing team driving innovation in critical care and anaesthesia.
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
We look forward to receiving your application at [email protected]
If you have any questions, please contact [email protected]