Manager, Regulatory Affairs UK & IE

This is what you will do:

The Regulatory Affairs Manager works under the responsibility of the local Director Regulatory Affairs & Quality for UK & Ireland, to ensure regulatory compliance of Alexion’s local product portfolio with all applicable pharmaceutical regulations in accordance with the company's specifications and the applicable relevant regulations, processes and standards. The Regulatory Affairs Manager supports the local RA lead in interactions with the national Regulatory Authorities, i.e. MHRA and HPRA

You will be responsible for:

• Regulatory life cycle submissions to national competent authorities (NCA) as and when requieerd e.g. renewals variations, PSUR’s, MAAs, line extensions, educational materials etc.) and maintain such submissions in electronic systems          
• Liaise with NCA’s as and when required
• Updates, submission, and implementation of educational materials
• Updates, submission, and implementation of product information including packaging materials
• Compliance with the Risk Management Plan (i.e. update and submission of additional risk minimization measures aRMMs))
• Liaise with the LSO (Local Safety Officer) regarding implementation of aRMM’s
• Liaise with Quality to ensure regulatory compliance with Alexion’s quality management system (QMS)
• Liaise with Global Regulatory Affairs Leads (GRL’s) for assigned products
• Maintenance and review of local SOPs and work instructions
• Participation in regional cross-functional GxP forum

You will need to have:

• Bachelor’s degree preferably in life sciences
• Miniumum 5 years' experience in the pharma/biotech industry including experience in a similar position.
• Working knowledge of the local Agency regulations and industry standards pertaining to regulatory is essential
• Knowledge in pharmacovigilance and quality management system is highly preferred.
• Experience on regulatory submissions and general life cycle management a
• Proven track record of effective collaboration with local agency in gaining approvals and defending approved products.
• Strong knowledge of local regulatory environment and excellent understanding of all stages of drug development, including pre-approval and marketed compounds.

We would prefer for you to have:

• Strong knowledge of all aspects of regulatory submission requirements, gained in an affiliate role
• Knowledge of updating, implementing, and distributing of educational materials

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.