Barrington James are currently partnering a vaccine company which develops, manufactures and commercialises innovative specialty vaccines. The client is currently looking for a Regulatory Affairs Manager to support their Global Regulatory Operations.
Prepare regulatory documentation for submissions such as clinical trial applications, marketing authorization applications, variations, renewals, etc. Responsible for the good quality and conformity to regulatory requirements of the submissions. Consulted on regulatory strategy, plans and manufacturing change control proposals. Answer Health Authority inquiries according to timelines.
Master's degree in a life-science discipline from an accredited college or university. At least 5 years in a professional Regulatory Affairs role Excellent project management ability, attention to detail, and ability to manage operational interactions with CA's and vendors Experienced in working with Health Authorities and managing vendors Fluency in English and German, any other language is advantageous
This position is expected to be filled exceptionally quickly, so if you are interested in this role please apply and someone from Barrington James will get in contact with you.