My client is an innovative Biotechnology company currently growing their activities and currently looking for a Regulatory Affairs Director to join their office in the Netherlands
Accountable for the development and implementation of the regulatory strategy for one or more products in line with the objectives set by the project team and with the Company regulatory strategy, and for ensuring that the strategy is designed to deliver a rapid approval with a desired label.
You will actively participate in the facilitation of effective partnerships within the regulatory affairs function of the company and the drug development teams.
Lead and guide other Regulatory staff and with teams to develop and execute the regulatory strategy in order to guide early phase drug development.
You will be responsible for communication and interactions with FDA, EMA and other national Regulatory Authorities.
Ensure that the content, quality, and format of regulatory submissions comply with applicable regulations and guidelines.
Contribute to the design of the development strategy, particularly focusing regulatory aspects, for assigned products
Drive the preparation of regulatory applications, including Orphan Drug Applications, INDs/CTAs, Scientific Advice, Pediatric Investigational Plans and NDA/MAAs
Communicate with internal and external partners, including EMA, FDA and other Regulatory Authorities
Contribute to the implementation of systems & processes to enhance global business value
Contribute to the monitoring of the regulatory landscape to keep abreast of new developments and effectively communicate them across the company
Over 10 years experience in regulatory affairs and minimum 5 in a similar position and ideally experience with Gene therapies
Strategic leadership skills, with a strong ability to think strategically and critically evaluate regulatory risks in drug development activities.
Excellent knowledge and understanding of EU and US regulatory environments.
Strong knowledge and experience in all phases of drug development
Strong ability to work effectively with multiple disciplines and personalities, works both independently or collaboratively in a team structure.
Innovative, initiative, anticipating problems and effective problem solving, by providing creative solutions.
Able to work in a fast pace environment, strong project planning and management skills, able to prioritize multiple tasks
Excellent oral and written communication skills.
For more information please contact Noemie Oliva at firstname.lastname@example.org