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Regulatory Affairs Specialist (M/F/X)

Munich , Bavaria
Only English Required
Job Ref:
SciPro - ein Geschäftszweig der LHi Group GmbH
Job Description
Regulatory Affairs Specialist (m/f/x)

Munich east


My client located in the east of Munich is currently searching for a Regulatory Affairs Specialist to join their highly successful team. The company’s focus is on cardiovascular products and a growing range for dermatology, neurology, urology and oncology. You should have 1-2 years practical, first-hand experience of working in Regulatory Affairs. The perfect candidate got experience in working with eCTD submissions as well as DCP/MRP.

The role:

● eCTD document management

● Preparation (translation) and finalization of German technical and usage information based on English EU procedural texts (MRP / DCP)

● Coordination and timely response to shortcomings

● eCTD document management

● Testing and approval of print templates for packaging

Your Profile:

● Successfully completed science education (Pharmacy, CTA, PTA)

● Several years of hands-on experience with BfArM Submission Operations

(e-CTD, CESP, new submissions, approval masks, variations and change notifications)

● You must be a self-starter with an eager, proactive attitude with strong communication skills

● Fluency in both English and German is a must

Munich is one of the economically most successful and fastest growing cities in Europe. In the city placements of the consultancy Mercer Munich occupied in 2018 among 231 major cities worldwide the third place for quality of life. According to the magazine Monocle, in 2018 it was even the most liveable city in the world.

If you are interested in the position, or know anyone that would be interested, I would be happy to talk to you in person in a confidential conversation.

Please contact Sebastian Gotzler at +49 89/21 09 49 06 or #removed# for more details.
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