About the job

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

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.

Education

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

Experience

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

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

Publish Date

07 October, 2021

Spontaneous Application

Regulatory Affairs Specialist 438

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

Apply