Serve as the local representative for regulatory affairs and quality assurance
Provide leadership, direction, and oversight of all regulatory affairs and quality activities related to the company's portfolio in Germany and Austria
Ensure quality oversight of training and train local staff in regulatory policies or procedures, support local compliance initiatives
Review and approval local versions of SmPC, labels and package leaflets, and artwork
Represent the organization before national regulatory agencies on major policy matters or decisions regarding company products
Local responsible person for quality and local contact person for product defects, product recalls, and crisis management
Local responsible person for regulatory affairs and review and approval of all medical, sales and marketing activities requiring a (HCP-) compliance check in line with SOPs and local laws and requirements (AMG, Pharma Code of conduct, etc.)


University undergraduate degree in life science/pharmacy (minimum)
Higher qualifications (MD, PhD, MBA) (advantageous)
Ability to work independently and effectively handle multiple priorities in a fast-paced environment
Excellent interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organization
Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook
Willingness to travel up to 30%