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Manager Regulatory Affairs

Workscope: Regulatory Affairs

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For our customer of the pharmaceutical Industrie located in Munich, we are looking for a talented

Manager Regulatory Affairs (m/w)

You support the regulatory function in Germany with all launch preparations and maintenance work around submissions and license management including medicinal products and clinical trial management. 
 
Daily agenda:
  • Be responsible for regulatory activities of 5 marketed products and investigational products: be a consultant for cross-functional teams and communicate local requirements. Communicate scientific and company policies and procedures
  • Be the regulatory point of contact for the local product team! Present project status and strategy approaches
  • Be responsible for German initial clinical trial submissions and subsequent submission of amendments or supplements 
  • Participate in the preparation of scientific advice meetings for development products, e.g. on request from German authorities 
  • Create and take care of contacts with German authorities and build upon an existing network of regulatory contacts
  • Provide regulatory expertise to labeling changes and submission teams 
  • Ensure product packaging, associated information updates in accordance with product licenses

Five dynamic colleagues are waiting for you. Complete up to 6th with your expertise:
  • University degree in natural sciences, life sciences or pharmacy
  • 3 - 6 years of solid experience in the field of Regulatory Affairs
  • University degree in natural sciences, life sciences or pharmacy
  • Musthave: deep knowledge of German regulatory requirements 
  • First points of contact with marketing/commercial aspects is a big advantage
  • Interesting and outgoing personality with excellent verbal and written communication skills in English and German

Does all of this sound interesting and challenging for your? If so, please apply online for this great opportunity. You only need your name, address, email-address and your CV to register within three minutes. All other documents will be on request!
Do not hestitate to contact us by phone 089 3840907 for your questions and further assistance!
 
Dr. Sarah Wälde
Kelly Services München
karriere.science.muenchen@kellyservices.de
T: 089-3840907

Contact detail


How to apply:
CV, Cover letter
Send application to
Dr. Sarah Wälde
Kelly Services München
karriere.science.muenchen@kellyservices.de
T: 089-3840907

Job profile


Working hours
Full-Time
Contract duration
Permanent
Type of job
Specialist
Work experience
jobexperience is required
Region
Germany (Bayern)
Working place
80339 München
Area of expertise
Pharmaceutics