CMC Regulatory Affairs Promising Start-Up

International Start-up is currently looking for a new CMC Regulatory Affairs Manager to join his team in Munich area

What you will get from this company:

• Very interesting products - Third generation Biosimilars which will significantly strength your scientific profile
• Personally building an international business, so that in few years you can have a very visible position on the European scene
• Very open minded environment, in which you can freely discuss and realize your ideas, so that you can truly test your skills!

Your tasks:

• Responsibility of IND and CMC documentation
• Contact to national and international regulatory authorities for quality-related issues
• Cooperation with R&D department and external partner for the development of the products

Your profile:

• 3 to 6 years experience in regulatory affairs management ( life cycle management, IND/CTA)
• Solid experience in writing the module 3 for large molecules products
• High command of English, written and oral
• Ability to work in a matrix organization

Starting Datum: ASAP

Location: Munich Area

Salary: Negotiable according to experience

If you feel interested in principle, feel free to contact Dr Emma Fleury, preferably by emai: E.Fleury@nonstop-recruitment.com / TEL. 0049 89 109 33 63

Feel free to check my Linkedin Profil: https://www.linkedin.com/in/dr-emma-fleury-023790a2/

It goes without saying, but if you help us referring someone from your network, you will get a little 'Thank you' gift from us!

NonStop Recruitment is a Swiss-headquartered, pan-European specialist recruitment consultancy. NonStop comprises a number of brands each covering a particular sector and with teams of consultants focusing on specific niches. NonStop offices across Europe provide licenced contract or labour leasing solutions, as well as permanent recruitment and executive search solutions. We are dedicated to fulfilling the expectations of our customers. Our unique in-house Quality Assurance function builds on and re-enforces a strong culture of ethics and customer service. For more information, see our website http://www.nonstop-recruitment.com

Key Words

Regulatory Affairs, CMC, Modul 3, Chemistry Manufacturing Control, Change Control, Variation, Änderung, IND, Investigational New Product, CTA, Clinical Trial Authorization, Clinical Trial Application, Life Cycle Management, Einreichung, Submission, Zulassung, Registration, EMA, European Medicines Agency, Paul Ehrlich Institute, FDA, Food and Drug Administration, GMP, Good Manufacturing Practice, Quality, Qualität, Qualitätssicherung, Large Molecules, große Moleküle, Biologics, Biosimilars, dritte Generation, third wave, R&D, Research and Development, Forschung und Entwicklung, F&E, cooperation, Kooperation, Business-Oriented, Entrepreneurial, Unternehmerisch, Aufgeschlossen, Geschäft, Matrix-Organization, Small Company, kleine Firma, kleines Unternehmen, Small Business, Germany, Deutschland, Munich, München, Bavaria, Bayern, Englisch-Speaking Position, Englischsprachige Positionen