QbD Austria, part of the international QbD group, is a young and growing consulting company offering services and training on regulatory affairs, regulatory compliance, business organization and quality assurance in the pharmaceutical, food supplement and medical device industry. Our headquarters are located in Vienna.
 

What do we expect from you as Consultant Regulatory Affairs CMC ?

• You deal with and respond to routine regulatory queries for information and documents in a timely, priority driven manner. 
• You prepare, compile, review and/or submit regulatory documentation to regulatory authorities an Notified Bodies. 
• You write Module 3 documents – CMC.
• You draft & review INDs/IMPDs for biopharmaceuticals.
• You handle licensing and post licensing procedures on behalf of clients including clinical Trial Applications, National, Mutual Recognition and Centralized Applications, medical device CE marking and food supplement notifications.
• You complete International product registrations and export certifications as requested by clients and international regulatory agencies in the EU and in third countries. 
• You perform dossier and development gap analysis (drugs, food supplements) and maintain current technical files and declarations of conformity in accordance with the Medical Device Directives. 
• You respond to customer queries and questionnaires for regulatory information.

Who are we looking for ?

• You have a master’s degree (PhD preferred) in a relevant subject: biotechnology, chemistry, biology or a similar background. 
• You have 3-5 years of experience in a similar position.
• You have experience with writing module 3 documents, CMC and IMPDs.
• You are proficient in English and German. Other languages are a plus.
• You are able and willing to learn legal aspects of drug, medical device and food registrations.
• You are computer proficient and can working with a variety of databases, word processing, spreadsheet, etc.
• Experience with vaccines and biotech products is a plus.
• You are able to create effective reports and analysis and you can communicate them in a timely and effective manner. 
• You are able to work in a team environment with shifting priorities and requirements. 
• You have excellent communications and organizational skills.
• You are willing to work at client sites in Europe. 
• A true QbD’er can be recognized by the following qualities:
  • Resilient: Your strong and positive attitude helps you overcome any challenge
  • Hungry for knowledge: You are always open to learning
  • No nonsense mentality: you can be straightforward in a respectful way
  • Innovative: You are constantly looking for new and better solutions
  • (Not too) serious: your job is serious, but you don’t take yourself too seriously.

What’s in it for you?

• QbD offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
• Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed. 
• As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
• Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together 
• Our promise to you: 
  • As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
  • Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
  • In short … We stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done! 

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!