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Table of Contents
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 RA Specialist China?
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 in China . You write Module 3 documents – CMC for biopharmaceuticals. You draft & review INDs/IMPDs for biopharmaceuticals . You handle licensing and post licensing procedures on behalf of clients including clinical Trial Applications, Marketing Authorization in China. 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 for China . You are proficient in English and Chinese/Mandarin . 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 complete salary package. Salary will be based on experience but will meet the legal requirements according to the Austrian laws and regulations. We invest in sustainable careers and meaningful connections We are a knowledge based company You'll work for an international award winning company 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 doneInterested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family
