Regulatory Affairs Labelling Manager Biosimilars - Austria
- Employer
- NonStop Consulting
- Location
- Austria
- Salary
- Negotiable
- Closing date
- Feb 10, 2018
View more
- Sector
- Pharmaceutical, Regulatory Affairs
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Clinical Practice
Job Details
NonStop is currently working with an expanding pharmaceutical company that has more than 20 offices worldwide. They are looking for a Labelling Manager to join their team. You will have an opportunity to deepen your knowledge in the most demanded area within the pharmaceutical industry - biosimilars. There are not so many labelling specialists in this field at the moment so you will have a chance to become an expert in this area and thus benefit to your career growth.
Moreover, you will deal with European and US submissions as well as emerging markets. This will strengthen your international profile and also profit your personal and professional development.
Furthermore, the company is a part of a bigger well-established conglomeration. In the future, you could move within different companies worldwide and thus gain more experience and expand your knowledge.
Your responsibilities:
* Preparation of EU and US labelling documents (incl. coordination of artwork preparation and device labelling) for allocated development and registration projects according to valid internal policies and guidelines
* Provision of guidance for local preparation of labelling documents for regulatory submissions in other highly regulated and emerging markets
* Labelling support in all registration procedures and renewals in cooperation with other relevant departments
* Preparation of responses to labelling related queries from regulatory authorities
* Review of medical information material such as scientific pamphlets/brochures or web presence
Your profile:
* Education: University degree (PhD or alternatively Master with min 4 years relevant professional experience) in Chemistry, Pharmacy, Biology, Biotechnology or a similar education, further education in Regulatory Affairs/Labelling desirable
* Languages: English (fluent) / German (basics)
* Experience: Working experience in the pharmaceutical industry, ideally with labelling of pharmaceutical products or medical devices
Please let me know if you are interested in a new challenge.
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, Zulassung, labelling, labeling, Germany, Deutschland, Austria, Österreich, CCDS, SOP, label, labels, artwork, PIL
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.
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