Associate Director Regulatory Affairs (m/f/d)

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 responsible for the

Responsibilities

• 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

Requirements

• 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 beneficial

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 recruiting@paion.com

If you have any questions, please contact HR@paion.com