Regulatory Affairs Specialist 438

About the job

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

About us

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.

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

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