Regulatory Affairs Manager - Germany

Mar 05, 2018
Apr 04, 2018
Kate Keller
Organization Type
Clinical Practice
Contract Type
Full Time

NonStop is currently working with a research-driven pharmaceutical company specializing in innovative medicines. They are looking for a Global CMC manager to strengthen their team. Your main responsibilities will focus on managing CMC regulatory tasks on a global scale for products in development as well as during product life cycle. So you will have an opportunity to expand your practical experience in more than one specific CMC module what is crucial for becoming a CMC expert.
Moreover, you will enjoy open and collaborative company culture. With nearly 50,000 employees, they still remain a family company. The client's goal is therefore to create pleasant and transparent environment for their co-workers. This is a great opportunity for those who value work and life balance.

Your responsibilities:
* represent the department in international project teams and provide regulatory advice regarding global regulatory requirements, submission strategies and opportunities for seeking scientific advice from health authorities
* guide project teams to prepare high quality global registration documents and responses to health authority requests while ensuring that timelines are met
* plan, define, review and compile global Module 3 documentation for Clinical Trial Applications and Marketing Authorisation Applications as well as for post approval CMC activities (e.g. CMC changes and renewals)
* review CMC documentation for in-licensing products
* maintain up-to-date knowledge and expertise within the global CMC regulatory environment (ICH, FDA, EMA)

Your profile:
* Bachelor or master's degree in Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology with relevant work experience required
* CMC regulatory experience in small molecules
* Fluency in English and proficiency in German (B2 level)

If interested, please send your CV in MS Word format (I am unable to accept PDF copies!) or contact me for a further confidential discussion
Kate Keller
Tel: +49 8921093363 | Ext: 3255

Not what you are looking for? Feel free to pass this information on to friends or colleagues that might be interested. NonStop has an excellent referral policy in place.

NonStop Recruitment 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, Switzerland 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.

What I offer: As a specialist Consultant within Regulatory Affairs for the pharmaceutical industry, I can offer: market knowledge and a personal service, therefore not just finding you suitable roles but in addition to this offering accurate and honest advice about salaries, work conditions and department reputations for positions across Germany and the EU.

regulatory affairs, RA, submissions, manager, zulassung, CTD, eCTD, germany, Deutschland, Dortmund, CMC, module 3, global manager, animal healthcare, biotech, biotechnology, ICH, FDA, EMA

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