REGULATORY AFFAIRS MANAGER

Regulatory Affairs Manager Biologics – CMCLocation: London Paddington/Belfast/BarcelonaPermanent - Full timeHybrid Role - 2 days in the officeCompensation: Competitive basic salary + Benefits including healthcare, enhanced pension, bonus, paid sabbaticalG&L Healthcare is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality consultancy work – and we are rapidly growing! Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements are exceeded.We now have multiple opportunities in our offices in either London Paddington, Belfast or Barcelona offices. You’d be joining our international team of experienced Regulatory professionals who manage multiple global projects for a wide variety of clients; from giant pharma to niche biotech’s. A day in the life of one of our consultants may be varied and unpredictable – this opportunity is ideal for someone who thrives on challenges, enjoys client interaction, and guiding client programs through complex regulatory strategies. The successful candidate will be completely solutions-orientated with well-developed client management and customer service skillsets.The ideal candidates will have:7-10+ years broad regulatory affairs experience, spanning small and large molecules (Biologics experience is a plus). Our client projects are diverse – so we are looking for someone who is comfortable with varying challenges. Extensive experience of CMC and post-approval regulatory requirements across global environments Capable track record with experience of RIMS (Veeva Vault beneficial), validation of systems and processes, quality assurance oversight, and auditing. Extensive experience with European regulatory affairs including regulatory strategy and plans for post-approval CMC activities quality services, dossier builds, and global post-approval maintenance work. Ideally, experience with all European procedures (MRP, CP, DCP) as well as direct contact with the Health Authorities. The successful candidate will represent G&L to our clients and the agencies – so interpersonal skills are paramount.Experience with large and small team management – acting as mentor to junior staff, developing individual training programmes. Our company is all about the successful development of our colleague – so the right candidate should have a passion for meritocracy, recognition and development.Natural aptitude for working in client-facing environments, experience with designing, running, and executing customized client projects. Additionally, the candidate should have experience with managing projects, including resource management, working across departments, budgeting and client deliverables.Personality TraitsYour daily workload will be varied, fluid, and completely responsive to our clients’ requests. We need someone who is an excellent communicator, a selfless team player, a brilliant multitasker – but most of all, someone who has a good sense of humour! We want to enjoy our work, have a happy office and consistently deliver exceptional services to our customers – so we are only recruiting people with a can-do, why-not, positive attitude.G&L Healthcare is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.