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Senior RA Manager - Diverse Projects

Employer
NonStop Consulting
Location
Mannheim
Salary
Negotiable
Closing date
Mar 19, 2018

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Sector
Pharmaceutical, Regulatory Affairs
Contract Type
Employee
Hours
Full Time
Organization Type
Clinical Practice

Job Details

NonStop is currently working with an international leading service provider specializing in Regulatory Affairs within the pharma industry. You will work on different projects in regulatory submissions and compliance with a focus on CMC, both small and large molecules. So you will have an opportunity to gain insight into variety of pharmaceutical products and deepen your knowledge in CMC field. This is a great opportunity for ambitious professionals who want to become experts in their area. Moreover, it's a permanent position. This means that you will be paid even if projects slow down.


You will also have a chance to gain intercultural experience as the company works with clients worldwide. You will go on business trips and help onsite and so gain deeper understanding of regulatory requirements across the globe. This is a great opportunity to expand your knowledge and gain new experiences what will benefit your personal and professional growth.


Your responsibilities:

*Compile and check pharmaceutical quality documentation for national and international markets

* Prepare Gap Analyses of pharmaceutical quality dossiers in the context of marketing authorization projects

* Prepare CMC responses to health authority questions during product registration

* Set up responses to deficiency letters from authorities

* Supervise development projects and marketing authorization procedures with regard to the pharmaceutical quality documentation

* Coordinate and perform Life Cycle Management processes


Your profile:
* Degree in life sciences
* Practical experience in regulatory submissions
* Fluency in English, spoken and written
* Basic German is an advantage


Location: Mannheim


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
E-mail: K.Keller@nonstop-recruitment.com

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

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

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