CMC Regulatory Affairs - Munich - Niche Products

Small matrix organization is currently looking for a new CMC Regulatory Affairs Manager (m/w) to join his team in Munich.

The company is very science-oriented, namely they are involved in the development and production of products from large molecules, which represent the newest trend in the pharmaceutical industry. Joining this company will allow the candidate to significantly develop own scientific and technical skills - and a lot of fun!

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

Contract Type: Permanent

Salary: Negotiable according to experience

If you feel interested in principle, feel free to contact Dr Emma Fleury, preferably by email: E.Fleury@nonstop-recruitment.com / TEL 0049 892 109 33 63

If you want direclt apply, please send your CV in WORD.DOC format to the aforementioned email adress

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, BfArM, Bundesinstitut für Arzneimittel und Medizintechnik, FDA, Food and Drug Administration, GMP, Good Manufacturing Practice, Quality, Qualität, Qualitätssicherung, Large Molecules, große Moleküle, Biologics, Biosimilars, third wave, dritte Generation, 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