Regulatory Specialist - CMC

REGULATORY CMC SPECIALIST

A young pharmaceutical company with a portfolio of generic and innovative products in the dermatology indication area is seeking a new member to their team. The company have products already marketed in 7 EU countries and are looking to expand their scope worldwide.

The company is owner-managed, meaning you have close interactions with the decision makers, and the small department is run by a highly experienced regulatory professional meaning there will be excellent opportunities for effective learning.

The scope of work will be very broad, with a focus on regulatory affairs in the area of CMC. You will not be pigeon-holed into minimal tasks and be able to get a solid overview of the processes involved.

The company is located around 30km east of Berlin, with a direct transport link via S-Bahn.

INDUSTRY : PHARMACEUTICAL

LOCATION : Berlin Area - East

SALARY RANGE : TO BE DISCUSSED

RESPONSIBILITIES :

· Cooperation with general functions for the maintenance and creation of the quality (CMC) part of the registration dossier

· Creation of the documentation for the approval extension and for change notifications taking into account the respective country requirements

· Analysis of the existing CMC documentation with regard to completeness and compliance with the current regulatory quality standards.

REQUIREMENTS :

· A completed qualification in Pharmacy or Chemistry

· 2+ years of Regulatory experience, ideally in the area of CMC

· Business fluency in German

If this sounds like a good match for your profile, apply now and your application will always be followed up with a response. If you are looking for something new but this isn't quite right for you, then get in touch for a confidential consultation:

Email: R.Martin@nonstop-recruitment.com
Phone: +49 892 109 3363
Internal Extension: 3490

Raymond Martin is a recruiter and head-hunter with a focus on the German Regulatory Affairs Market. He assists candidates and clients alike with recruitment related topics.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover