Regulatory Affairs Manager Pharma (m/f/d)
- Specialized in CMC -
Permanent position, full-time
Are you looking for a varied occupation?
Would you like to develop your professional skills?
Do you appreciate flexible working arrangements in order to reconcile work and private life?
Is a friendly working environment important to you?
Then we should get to know each other!
acora pharma GmbH is a consultancy in Drug Regulatory Affairs based in Cologne. We have been assisting our national and global clients for nearly 20 years.
- Preparation and updating of CMC documentations for national and international marketing authorizations
- Writing of Quality Overall Summaries
- Preparation and submission of marketing authorization applications (national, MRP, DCP), renewals and variations
- Answering deficiency letters
- Life cycle management
- Assessment of Module 3 dossiers
- Preparation of eCTDs
- Correspondence with clients in Germany and abroad as well as regulatory authorities
- University degree in Pharmacy, Biology or Chemistry
- Several years of experience in the preparation of CMC documentation
- Very good command of German and English
- Well-structured working style and good organizational skills
- Ability to work in a team, social skills
- Competent handling of MS Office programs and document management systems
We are looking forward to receiving your application documents stating your earliest possible starting date and salary expectations.
acora pharma GmbH
Dr. Martina Jaworek