CMC Regulatory Affairs - New Position - Start Up

My client is a small start up in the Munich area, responsible for the development and the manufacturing of Third Generation Biosimilars. His ambitious and scientifically challenging projects have attracted many founding, so that he has newly opened a new position for a CMC Regulatory Affairs Manager (m/w).

The company was founded in 2014, and since that year it is constantly growing, so that they can offer the financial stability of a big company and that the open minded environment of a start up. If you are looking for a company in which you can have hands-on tasks and autonomy for realising your own ideas, you will be more than welcome!

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 me. Preferably write me an email, so that we can set up an appointment to talk: E.Fleury@nonstop-recruitment.com / TEL 0049 892 109 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