Project Manager CMC - Great Opportunity for Young Professionals

Jan 15, 2018
Feb 14, 2018
Kate Keller
Jobseeker Type
Organization Type
Clinical Practice
Contract Type
Full Time

NonStop's client is an expanding pharmaceutical company specializing in oncology-based products. They are now looking for a CMC specialist to support their multi-skilled team. You will concentrate not only on one specific CMC module but take products through the whole process of development - from the concept to the final authorisation. So you will have an opportunity to gain practical experience of the full life cycle what is crucial for becoming a CMC expert.

Moreover, you will closely work with other departments - QA, QC and R&D - on the same product. That's a great opportunity to get involved and understand how other divisions interact. This is an essential key to understanding stakeholder management and thus to your career progression.

This is an exciting opportunity for younger RA professionals as it offers insight into the full life cycle, as well as the basis of understanding of stakeholder management. These skills are necessary for anybody who is seeking a career in RA. Furthermore, the company is a part of a bigger well-established organisation. In the future, you could move within three different companies and thus gain more experience and deepen your knowledge.

Your responsibilities:
* Write CMC documentation according to agreed CMC regulatory strategies to obtain rapid registrations of new products world-wide
* Prepare CMC responses to health authority questions during product registration
* Contribute as Development Regulatory Centre (DRC) CMC expert to technical project teams during product development
* Support and/or lead DRC related projects

Your profile:
* Degree in life sciences (Chemistry, Biochemistry or equivalent area).
* Experience in CMC documentation within the pharmaceutical industry
* Fluency in English

Work contract: either 2 years or permanent

Location: Austria

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, mannheim, CMC, module 3, Austria