Reporting to Associate Director, Global Regulatory Affairs, CMC, your main responsibilities will be as listed below. You will be working with an innovative gene therapy project, which is new to the company and for which the regulatory strategy is currently being developed. We are looking for a strong candidate, who can actively drive and support the global project team in bringing this product to the market, including the following activities:
You will be working in an international environment and have interfaces with many different disciplines including other Regulatory disciplines, Global Pharmaceutical R&D, Product Supply, Ferring’s affiliates and development sites around the world.
The ideal candidate holds a degree in life science or Pharmacy, with at least 7 years of global RA experience for a Senior position. Since gene therapy is a new modality in the portfolio, regulatory CMC experience with advanced therapy products is preferred. However, regulatory experience with biologics/biotech will also be considered.
You must have a proactive mindset and a desire to continuously develop and find innovative solutions to regulatory challenges, which you are able to communicate well verbally and in writing. In addition, you are well-organized and have the ability to plan, execute and meet deadlines. You have good negotiation skills and can deal with ambiguity. You are a true team player, an experienced user of IT (including MS Office), and are keen on working in a multicultural corporate environment.