G&L Scientific is a specialist provider to the healthcare industry for all aspects of Regulatory Affairs support. Founded in 2015, we have rapidly grown on a global scale, with more than 200 colleagues across our offices in UK, US, Canada and India. 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 opened an entity in Spain in 2020 and are now recruiting for an experienced Regulatory professional to help us build our presence there. We are looking for a unique person who has the technical RA experience to work on our client projects, but also has an entrepreneurial, proactive outlook and would enjoy building our new entity. You would be involved in all aspects of our Spanish office – recruitment, facilities, project work, team management – the list is endless.
We need someone who can join and potentially lead global projects and international teams, working closely with G&L colleagues and client stakeholders. Your daily workload will be fluid and completely responsive to our clients’ requests – and no project is the same. We are looking for an excellent communicator (must speak business English as well as native Spanish), 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.
Part of your role will be to develop the relationships G&L has with our Spanish client base; there may be governance meetings for existing projects or sales pitches, working closely with our commercial team. You would be an ambassador for G&L across Europe, reporting directly to head office in the UK.
We are looking for additional EU strategists to join our EU team of consultants. We have a number of long term, short term and ad-hoc projects where we need to draw on senior-level RA Leads.
Typical and recently projects have included the following:
- Working with US based Biopharma who are looking to launch products in the EU and need strategy and guidance
- Working with small companies who need ad-hoc strategic advice, problem solving and advice on which approach to take with MHRA.
- Conducting a gap analysis of a global clinical development plan prior to Agency interactions
- Developing strategies for how to get the product approved in Europe
- Advising on timings and approaches for seeking EMA advice or Scientific Advice
- Providing input to PIP, orphan, rare disease strategies
- Advising on Clinical and Non-Clinical strategic components of reg strategies
- Advising on the EU SME status
The ideal consultant would have vast Regulatory Strategy experience, including:
- 10+ years broad regulatory experience, ideally spanning pharmaceuticals, consumer healthcare, biotechnology and animal health products. Our projects are diverse – so we are looking for someone who can turn their hand to anything!
- Experience dealing directly with the MHRA, EMA and FDA
- Experience in clinical and non-clinical work
- Development experience
- EMA Scientific Advice experience
- FDA Briefing Meetings experience
- Knowledge of multiple therapy areas, potentially gene and cell therapy experience
- You will represent G&L to our clients and the agencies – so interpersonal skills are paramount.
- Experience of management – both project and people; acting as mentor to junior staff, developing individual training programmes. Our company is all about our people – so you should have a passion for meritocracy, recognition and development.
- Experience of working in client-facing environment, experience of designing, running and executing bespoke client projects. Experience of managing projects, including resource management, budgeting, timelines and deliverables. Previously working for a consultancy would be an advantage.
If you would like to hear more, please send your details to firstname.lastname@example.org
G&L Scientific 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.