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Sr CMC Regulatory – Biotech – Growing Company, München



München, Germany 

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Job Reference:

181776 3_1520423768

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Job Description:

I am currently looking for a Senior CMC Regulatory Affairs Manager (m/w) to join a small biotech company in the Munich area.

Founded in 2013 the company has been constantly growing, namely this position is a brand new one, no replacement! The regulatory team is also planning further expansion for the next years, as the products are doing very well on the market, so that you can have good career possibilities in this environment. The Senior Role can be your chance to prove your leadership and technical skills, as you will play a key role for the guidelines realization within the company. If you are successful, you could be the next project manager or team leader, as internal candidates have always a big advantage.

Your tasks

* You take part to the creation and compilation of module 3 and all relevant registration texts, like variations, renewals etc.
* Responsibility for the correct interpretation and realization of all national and international CMC guidelines
* You are the contact person for the relevant national and international authorities and external stakeholders
* You take part to the change control tasks

Your profile

* 5+ years in writing module 3 for biosimilar
* Solid experience in international registrations

Starting Datum: ASAP

Location: Munich Area

Salary: Negotiable according to experience

Contract Type: Permanent position, full time

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, 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, Large Molecules, große Moleküle, Biologics, Biosimilars, Biotech, dritte Generation, third wave, Business-Oriented, Matrix-Organization, Small Company, kleine Firma, kleines Unternehmen, Small Business, Germany, Deutschland, Munich, München, Bavaria, Bayern, Englisch-Speaking Position, Englischsprachige Position, Senior

Job Requirements:

*5+ years in writing modul 3 for biosimilar *Solid experience in international registrations
Company Info
NonStop Recruitment
25 Canada Square, Canary Wharf
London, United Kingdom
Phone: +44 0207 234 0550
Web Site:
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