Regulatory Affairs Manager EU -12 months

About the Company A global biotech organisation with a strong pipeline of development and commercial products across multiple therapeutic areas is looking for a 12-month reg manager to join the team with scope to extend. Fully remote but you must be based in the UK. You will be responsible for supporting at least 3 projects, which could be in development or marked products. Responsibilities • Manage CTA, MAA and post-approval regulatory submissions across Europe. • Support regulatory strategy for development and marketed products. • Provide regulatory guidance to cross-functional project teams. • Support interactions with health authorities, including scientific advice and accelerated pathways. • Contribute to labelling activities and life cycle management. • Monitor regulatory changes and assess business impact. • Conduct regulatory intelligence to support product development and submission planning. Requirements • 5+ years Regulatory Affairs experience within pharma or biotech. • Strong knowledge of EU CTR and MAA procedures. • Understanding of drug development and LCM lifecycle management. • Excellent communication and stakeholder management skills. Please apply now or reach out to hear more details.