Regulatory Affairs Manager EU

Regulatory Affairs Manager EU, clinical trials, post approvalYour new company An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to join a leading global biotechnology organisation. Working within the European Regulatory Affairs team, you will play a critical role in supporting the development, approval and life cycle management of innovative medicines across a diverse portfolio spanning metabolic, cardiovascular, inflammatory, endocrine and bone diseases, as well as biosimilars.This role offers the opportunity to work on products from early clinical development through to marketing authorisation and post-approval activities, collaborating with cross-functional teams across Europe and globally.Your new role As a key member of the Regulatory Affairs function, you will be responsible for supporting regional regulatory strategies and ensuring the successful planning and execution of regulatory submissions in line with business objectives and evolving regulatory requirements.Key ResponsibilitiesPlan, prepare and manage regulatory submissions, including clinical trial applications and marketing authorisation activities.Support the implementation of regional regulatory strategies across a portfolio of development and commercial products.Provide regulatory expertise and guidance to cross-functional teams on European regulatory requirements and pathways.Contribute to the development of regulatory documentation and support interactions with health ..... full job details .....