About the job

We are seeking for a Regulatory Affairs Specialist responsible for ensuring the delivery of regulatory activities performed onsite.

About us

Group 10
Responsibilities

  • Ensure that the regulatory tasks and functions within the Regulatory Affairs Department are carried out efficiently and effectively.
  • Obtaining and maintaining marketing authorisation approval for the Company’s products.
  • Providing strategic regulatory input from local market to drug development, e.g. biologics, innovation, rare.
  • Secure essential interface with EU Regional Leads.
  • Maintaining strong and positive working relationships with the Health Authorities in the DE, Global Regulatory Affairs (GRA) and other key Global Departments.

Group 11
Education

  • Higher degree in Life Science, PhD in pharma is an asset

Group 12
Experience

  • Minimum of 5 years ‘experience, in regulatory affairs for pharmaceutical products

Group 13
Skills

  • Knowledge and understanding of the pharmaceutical industry, particularly the Medical, Commercial, Market Access, Research and
    Information functions
  • Familiar with BfArM and PEI Front End, electronic document and information management systems (eg Veeva, eRIMS, eDOC and MyDoc)
    and IT systems (eg MS Word, Excel, Power Point, Lotus Note and Outlook)
  • Mastering of English and German language is key for business continuity
  • Good management skills
  • Ability to work in a fast paced environment
  • Entrepreneurial mindset
  • Change facilitator
  • Good stress management
  • Excellent communicator

Regulatory Affairs Specialist 315